July 3, 2012

URGENT MEDICAL DEVICE RECALL (REMOVAL)
Certain lots of STERRAD® CYCLESURE® 24 Biological Indicator

 

 

Dear Valued Customer,

This communication is to alert you that Advanced Sterilization Products (ASP) is recalling (removing) certain lots of the STERRAD® CYCLESURE® 24 Biological Indicator (BI) product. ASP recently determined that it does not have adequate data to support the entire duration of the product’s labeled shelf-life. As a result, ASP is asking for customers to take inventory of their STERRAD® CYCLESURE® 24 Biological Indicator (BI) supply and review each case against the revised shelf-life for the product pursuant to the instructions set forth in the “What Action Is Required” section below. All customers should discontinue the use of product from lots of STERRAD® CYCLESURE® 24 Biological Indicators (BIs) that exceed the newly determined expiration date and return the affected product(s). Use of expired product may result in not being able to verify proper sterilization conditions.

Should you determine that you have expired STERRAD® CYCLESURE® 24 Biological Indicators (BIs) or have any questions about your current inventory, you must contact Stericycle (see below) for further instructions.

What Action Is Required?

Please examine the expiration date printed on packaging components of STERRAD® CYCLESURE® 24 Biological Indicator (BI) as pictured in Figure 1, and see the table in Addendum 1 listing each affected Lot Number, Current Expiration Date on Label and New Expiration Date Based on Conversion (reducing the printed expiration date by nine (9) months) to verify the correct expiration date.


FIGURE 1: Location of expiration date on product labeling

Should you determine that you have expired STERRAD® CYCLESURE® 24 Biological Indicators, expired product should be returned immediately in accordance with the “Product Return Instructions” section below. ASP highly recommends that your facility manually re-label the non-expired product cases with the newly calculated expiration date so that your inventory is correctly labeled for your use. See conversion table in Addendum 1.

Provide this notice to anyone in your facility that needs to be informed. Maintain a copy of this notice with the affected product. If any of the STERRAD® CYCLESURE® 24 Biological Indicator (BI) product has been forwarded to another facility, contact that facility and arrange return. Maintain awareness of this notice until expired product listed above has been returned to ASP.

Why are you being contacted:

You are receiving this letter because our records indicate you have received affected product.

Product Return Instructions:

To assist ASP with replacing any affected product, please complete the following three (3) steps:

  1. Please examine your inventory and return all unused STERRAD® CYCLESURE® 24 Biological Indicator (BI) product that exceeds the newly determined expiration date, using the enclosed prepaid UPS return label to: Stericycle, 2670 Executive Drive Suite A, Indianapolis, IN 46241.
  2. Please physically count your inventory of product that exceeds the newly determined expiration date and record the data on the enclosed Business Reply Card and packing slip that are included with this letter.

  3. It is very important that you complete the requested information on the enclosed postage-paid Business Reply Card and return it to Stericycle. Please contact Stericycle at 1-877-907-7030 if you need additional packing labels. Stericycle’s hours of operation are Monday-Friday, 8 a.m.-5 p.m. ET.

If you have distributed the affected product to other locations within your healthcare system, please notify them of this recall and ask them to contact Stericycle at 1-877-907-7030 to arrange for return of the product. If you have any questions or further need assistance, please call Stericycle at 1-877-907-7030. Stericycle’s hours of operation are Monday-Friday, 8 a.m.-5 p.m. ET.

We understand the impact this product recall may have on your facility, and in order to help reduce the potential impact, we are placing STERRAD® CYCLESURE® 24 Biological Indicator (BI) product on manual allocation on an emergency-only basis. Only if you have no inventory or will deplete your inventory within seventy-two (72) hours will your order of STERRAD® CYCLESURE® 24 Biological Indicator (BI) product be fulfilled.

The United States Food and Drug Administration (FDA) has been notified and is aware that ASP is voluntarily taking this action. ASP apologizes for the inconvenience and understands that STERRAD® CYCLESURE® 24 Biological Indicator (BI) is a critical component of the sterilization process.

New Shipments of STERRAD® CYCLESURE® 24 Biological Indicator (BI) Product

Beginning July 9, 2012, ASP will begin shipping STERRAD® CYCLESURE® 24 Biological Indicator (BI) product with accurate expiration dates that do not require conversion. Customers will be able to differentiate between current product and the newly shipped product by the lot number.

  • Current product has a lot number containing six (6) characters, e.g. 123456
  • Newly Shipped product will have a lot number containing eight (8) characters, e.g. 123456EE

Thank you for your understanding and patience as ASP works diligently to correct this situation in a timely manner. Should you have additional questions, please contact Stericycle at 1-877-907-7030 or contact your ASP representative. Stericycle’s hours of operation are Monday-Friday, 8 a.m.-5 p.m. ET.

Sincerely,

Richard J. Alberti
Vice President, Quality Assurance and Regulatory Affairs
ASP

Addendum 1: Expiration Dates of Affected STERRAD® CYCLESURE® Biological Indicator (BI) Lots

Lot Current Expiration on Label New Expiration Date Based on Conversion (minus 9 months)    Lot Current Expiration on Label New Expiration Date Based on Conversion (minus 9 months) 
002127 2013-02 2012-05-31   086127 2013-05 2012-08-31
003127 2013-03 2012-06-30   087127 2013-05 2012-08-31
005127 2013-03 2012-06-30   089127 2013-05 2012-08-31
006127 2013-03 2012-06-30   090127 2013-05 2012-08-31
007127 2013.03 2012-06-30   091127 2013-05 2012-08-31
008127 2013-03 2012-06-30   092127 2013-05 2012-08-31
009127 2013-03 2012-06-30   093121 2013-05 2012-08-31
010127 2013-03 2012-06-30   094127 2013-05 2012-08-31
011127 2013-03 2012-06-30   095127 2013-06 2012-09-30
011128 2013-03 2012-06-30   100121 2013-05 2012-08-31
012127 2013-03 2012-06-30   100127 2013-06 2012-09-30
013127 2013-03 2012-06-30   101127 2013-06 2012-09-30
014127 2013-03 2012-06-30   102127 2013-06 2012-09-30
015127 2013-03 2012-06-30   104127 2013-06 2012-09-30
016127 2013-03 2012-06-30   107121 2013-06 2012-09-30
018127 2013-03 2012-06-30   107127 2013-06 2012-09-30
019127 2013-03 2012-06-30   107128 2013-06 2012-09-30
020127 2013-03 2012-06-30   109127 2013-06 2012-09-30
021127 2013-03 2012-06-30   109128 2013-06 2012-09-30
022127 2013-03 2012-06-30   110127 2013-06 2012-09-30
023127 2013-03 2012-06-30   111127 2013-06 2012-09-30
024127 2013-03 2012-06-30   114121 2013-06 2012-09-30
025127 2013-04 2012-07-31   114127 2013-06 2012-09-30
026127 2013-04 2012-07-31   118127 2013-06 2012-09-30
027127 2013-04 2012-07-31   121121 2013-06 2012-09-30
028127 2013-04 2012-07-31   121127 2013-06 2012-09-30
030127 2013-04 2012-07-31   122127 2013-06 2012-09-30
031127 2013-04 2012-07-31   123127 2013-06 2012-09-30
032127 2013-04 2012-07-31   124127 2013-06 2012-09-30
033127 2013-04 2012-07-31   125127 2013-06 2012-09-30
034127 2013-04 2012-07-31   128121 2013-06 2012-09-30
035127 2013-04 2012-07-31   128127 2013-06 2012-09-30
036127 2013-04 2012-07-31   129127 2013-06 2012-09-30
037127 2013-04 2012-07-31   130127 2013-06 2012-09-30
038121 2013-04 2012-07-31   131127 2013-06 2012-09-30
038127 2013-04 2012-07-31   132127 2013-06 2012-09-30
039127 2013-04 2012-07-31   135121 2013-06 2012-09-30
040127 2013-04 2012-07-31   135127 2013-06 2012-09-30
041121 2013-04 2012-07-31   136127 2013-07 2012-10-31
042127 2013-04 2012-07-31   137127 2013-07 2012-10-31
043127 2013-04 2012-07-31   138127 2013-07 2012-10-31
044127 2013-04 2012-07-31   139127 2013-06 2012-09-30
045121 2013-04 2012-07-31   142121 2013-06 2012-09-30
045127 2013-04 2012-07-31   142127 2013-07 2012-10-31
046127 2013-04 2012-07-31   143127 2013-07 2012-10-31
047127 2013-04 2012-07-31   144127 2013-07 2012-10-31
048127 2013-04 2012-07-31   145127 2013-07 2012-10-31
049127 2013-04 2012-07-31   146127 2013-07 2012-10-31
052127 2013-04 2012-07-31   150121 2013-06 2012-09-30
053121 2013-04 2012-07-31   150127 2013-07 2012-10-31
053127 2013-04 2012-07-31   151127 2013-07 2012-10-31
054127 2013-04 2012-07-31   152127 2013-07 2012-10-31
055121 2013-04 2012-07-31   152128 2013-07 2012-10-31
056127 2013-04 2012-07-31   156127 2013-07 2012-10-31
057127 2013-04 2012-07-31   157127 2013-07 2012-10-31
058127 2013-04 2012-07-31   158127 2013-07 2012-10-31
059127 2013-04 2012-07-31   159127 2013-07 2012-10-31
060127 2013-04 2012-07-31   160127 2013-06 2012-09-30
061127 2013-04 2012-07-31   163127 2013-07 2012-10-31
062121 2013-05 2012-08-31   164127 2013-08 2012-11-30
062127 2013-04 2012-07-31   165127 2013-08 2012-11-30
063127 2013-04 2012-07-31   339117 2013-02 2012-05-31
064127 2013-04 2012-07-31   340117 2013-02 2012-05-31
065127 2013-04 2012-07-31   341117 2013-02 2012-05-31
067127 2013-05 2012-08-31   342117 2013-02 2012-05-31
068127 2013-05 2012-08-31   343117 2013-02 2012-05-31
069121 2013-05 2012-08-31   344117 2013-02 2012-05-31
069127 2013-05 2012-08-31   345117 2013-02 2012-05-31
070127 2013-05 2012-08-31   346117 2013-02 2012-05-31
071127 2013-05 2012-08-31   347117 2013-02 2012-05-31
072127 2013-05 2012-08-31   348117 2013-02 2012-05-31
073127 2013-05 2012-08-31   349117 2013-02 2012-05-31
074127 2013-02 2012-05-31   350117 2013-02 2012-05-31
076121 2013-05 2012-08-31   351117 2013-02 2012-05-31
077127 2013-02 2012-05-31   352117 2013-02 2012-05-31
078127 2013-03 2012-06-30   353117 2013-02 2012-05-31
078128 2013-03 2012-06-30   354117 2013-02 2012-05-31
079127 2013-03 2012-06-30   355117 2013-02 2012-05-31
081127 2013-05 2012-08-31   357117 2013-02 2012-05-31
082127 2013-05 2012-08-31   360117 2013-03 2012-06-30
084127 2013-05 2012-08-31   362117 2013-03 2012-06-30
085127 2013-05 2012-08-31   363117 2013-03 2012-06-30
086121 2013-05 2012-08-31   364117 2013-02 2012-05-31

 

CO-1006234 CL-107822, Rev. A

 

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