seprafilm Procedure Pack ADHESION BARRIER recallZ-1855-2012 · Genzyme Corporation · initiated Jun 13, 2012
Class II Terminated All recalls posted in June 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Genzyme Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility of product may be compromised due to packaging defect
FDA root cause category: Packaging process control
What the company is doing
Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.
Recall details
- Recall number
- Z-1855-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 13, 2012
- Posted by the FDA
- Jun 21, 2012
- Recalling firm
- Genzyme Corporation
- Quantity
- 3880units
- Product code
- MCN
- FDA submissions
- P950034
- Distribution
- Worldwide Distribution - US (nationwide) and the country of S. Korea
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
Other devices under the same FDA submission
1 device cleared under P950034 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SEPRAFILM 430102Baxter Healthcare Corporation · Barrier, absorbable, adhesion1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 62127).
- Z-1856-2012 · Terminatedseprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotom…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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