CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report
seprafilm¿ Procedure Pack Adhesion Barrier Re recalled by Genzyme
Genzyme is recalling seprafilm¿ Procedure Pack Adhesion Barrier Re, distributed nationwide in the US. The recall was initiated on 13 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1855-2012
- FDA event ID
- 62127
- Recalling firm
- Genzyme, Framingham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2012
- FDA classified
- 21 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Jun 2012 | Recall initiated by company | |
| 21 Jun 2012 | Classified by FDA | +8 days |
| 27 Jun 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility of product may be compromised due to packaging defect
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Where it was distributed
Worldwide Distribution - US (nationwide) and the country of S. Korea
Questions about this recall
Why was it recalled?
Sterility of product may be compromised due to packaging defect
Which lots are affected?
Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
Where was it sold?
Worldwide Distribution - US (nationwide) and the country of S. Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 62127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | seprafilm¿ Single Site Adhesion Barrier Re recalled by Genzyme | Genzyme | Sterility | Nationwide |
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All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Clolar (clofarabine) 20 mg/ (1 mg/mL) Injection, for intravenous use recalled | Genzyme | Packaging Defects | Nationwide |
| Drug | CLASS III | Lumizyme (alglucosidase alpha), 50 mg/vial recalled by GenzymeLumizyme | Genzyme | Other | TN |
| Drug | CLASS II | Thyrogen (thyrotropin alfa for injection) recalled by Genzyme | Genzyme | Particulate Matter | Nationwide |
| Drug | CLASS II | Thyrogen (thyrotropin alfa for injection) recalled by GenzymeThyrogen | Genzyme | Particulate Matter | Nationwide |
| Device | CLASS II | seprafilm¿ Single Site Adhesion Barrier Re recalled by Genzyme | Genzyme | Sterility | Nationwide |
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