PDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use
Ethicon recalled 1,656 units of PDS Plus Antibacterial Suture due to potential breakage during surgery, which could compromise tissue approximation. The affected lot was distributed to the United Kingdom, Ireland, and Turkey.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—potential suture breakage during surgery—is theoretical. However, it qualifies as a risk-of-harm medical device product where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. has recalled 1,656 units of PDS Plus Antibacterial Suture (Product Code PDP9625H, Lot SCMAZH). This surgical suture is indicated for general soft tissue approximation and ligation, including use in pediatric cardiovascular applications.
The recalled sutures may experience breakage during intra-operative use. Breakage could result in failure to achieve tissue approximation and/or ligation, potentially compromising surgical outcomes.
The affected lot was distributed internationally to the United Kingdom, Ireland, and Turkey.
The recalled product
- Product
- PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Suture
- Affected units
- 1,656
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 (2)
- UDI-DI: (01)10705031124691 Primary (Individual Unit)
- (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH
Distribution
Distribution scope not specified by the agency.
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