Ethicon Recalls Surgical Sutures Due to Incomplete Labeling
Ethicon is recalling specific lots of Fast Absorbing Plain Gut sutures because the box and foil labels are incomplete.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to incomplete labeling, which falls under the 'packaging-only problems' or 'documentation issues' criteria for a Low severity score.
Plain-English summary
Ethicon, Inc. is recalling specific lots of Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture. The recall involves 1,922 units of the 5-0 (1.5 metric), 18-inch (45 cm) conventional cutting suture. The affected product is distributed nationwide in the United States and in Canada.
The recall was initiated because the labeling on the box and foil is incomplete. The source text does not specify which details are missing from the labels or if any adverse events have been reported.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Ethicon, Inc. according to their instructions.
The recalled product
- Product
- Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 1,922
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 (17)
- Product Code: 1915G (box label)
- 1915 (Tyvek/Foil label) Product Lot #'s JC6395
- JC6417
- JCK328
- JCK329
- JCK384
- JCK716
- JCM669
- JCM757
- JCZ987
- JC5020
- JC6710
- JCM535
- JCK330
- JCK460
- JCM668
- JC5629 and JCM475.
Distribution
Distributed nationwide across the United States.
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