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 |
Z320H |
Monocryl (Poliglecaprone 25) (Undyed) Suture |
UBMDKC |
Y416H |
PDS II (Polydiaxanone) Absorbable Suture |
UBMLSS |
Z320H |
Vicryl (Polyglactin 910) Absorbable Suture |
More than 10 numbers, contact manufacturer. |
J218H |
Monocryl Plus Antibacterial Suture |
UAMMCX |
MCP416H |
Vicryl (Polyglactin 910) Absorbable Suture |
More than 10 numbers, contact manufacturer. |
J218H |
Monocryl (Poliglecaprone 25) Suture (Undyed) |
UBMDKC |
Y416H |
Monocryl Plus Antibacterial Suture |
UAMMCX |
MCP416H |
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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