VICRYL™, PDS™, MONOCRYL™ and MONOCRYL™ Plus sutures
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| PDS (Polydioxanone) Monofilament Suture | UAMMSR UAMHRD | Z320H Z341H |
| Monocryl (Poliglecaprone 25) (Undyed) Suture | UBMDKC UAMPLA UAMKCL UAMPSC UAMLXX UBMHDD UAMKCD UAMRMZ UBMCAA | Y416H Y442H Y427H Y935H Y426H Y945H |
| PDS II (Polydiaxanone) Absorbable Suture | UBMLSS UAMMSR UAMHRD | Z320H Z341H Z149H |
| Vicryl (Polyglactin 910) Absorbable Suture | More than 10 numbers, contact manufacturer. | J218H J258H J317H J315H J345H J353H J426H J316H J327H J936H J214H J215H J423H J474H J458H J603H J699H |
| Monocryl Plus Antibacterial Suture | UAMMCX UAMQUZ UBMHLB UBMLKK UAMLTR UAMRUM UAMRKQ | MCP416H MCP426H MCP417H MCP340H MCP266H MCP427H MCP945H |
| Vicryl (Polyglactin 910) Absorbable Suture | More than 10 numbers, contact manufacturer. | J218H J258H J317H J315H J345H J353H J426H J316H J936H J214H J215H J423H J474H J603H J699H |
| Monocryl (Poliglecaprone 25) Suture (Undyed) | UBMDKC UAMPSC UAMLXX UBMHDD UAMKCD UAMRMZ UBMCAA | Y416H Y427H Y935H Y945H |
| Monocryl Plus Antibacterial Suture | UAMMCX UBMHLB UAMQUZ UAMLTR UBMLKK UAMRUM UAMRKQ | MCP416H MCP426H MCP417H MCP340H MCP266H MCP427H MCP945H |
Issue
Ethicon identified a manufacturing issue on a specific packaging machine that resulted in a hole in the primary packaging of a small percentage of VICRYL™, PDS™, MONOCRYL™ and MONOCRYL™ Plus sutures manufactured between January 27 and March 27, 2024. The occurrence of this defect is rare with an estimated rate of 0.011% of product presenting the condition (99.9% of product is not impacted by this defect). When present, the hole is always and only on the first package in the horizontal box of quantity 36, and it occurs in the same location on the bottom side foil cavity of the first package towards the peelable flaps.
Recall start date: May 20, 2024
Additional information
Details
Ethicon Inc.
1000 Route 202, Raritan, New Jersey, United States, 08869
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