Genzyme Recalls Seprafilm Adhesion Barrier Due to Packaging Sterility Risk
Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier because a packaging defect may compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier (Re-order Number: 6641-01). The recall is due to a packaging defect that may compromise the sterility of the product.
The affected product is indicated for use in patients undergoing abdominal or pelvic laparotomy to reduce postoperative adhesions. The recall covers Lot 11NP685, which has an expiration date of November 2014. The product was distributed nationwide in the United States and in South Korea.
Consumers and healthcare providers should stop using the affected product and contact Genzyme Corporation for further instructions or a replacement.
The recalled product
- Product
- seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 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…
- Manufacturer
- Genzyme Corporation
- Affected units
- 1,285
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 11NP685 . Exp 2014- 11
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Genzyme Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Genzyme Corporation
See all →- LowGenzyme Recalls Clolar Injection Due to Missing Package Insert
FDA (Drugs) · 2017-11-22
- LowGenzyme Recalls Lumizyme Vials Due to Incorrect or Missing Lot and Expiration Dates
FDA (Drugs) · 2016-04-06
- SevereGenzyme Recalls Thyrogen Injection Vials Due to Glass Particulate Matter
FDA (Drugs) · 2016-03-09
- SevereGenzyme Recalls Thyrogen Due to Glass Particles Found in Product
FDA (Drugs) · 2016-03-09
- HighGenzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect
FDA (Devices) · 2012-06-27
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateBaxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution
FDA (Devices) · 2024-05-01
- HighTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
- HighCeftazidime Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-02-01
- HighTerumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
FDA (Devices) · 2017-12-20
- SevereSentara Recalls Cefepime Homepumps Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-02-03
- HighAllergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns
FDA (Devices) · 2013-02-13