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COATED VICRYL RAPIDE SUTURE (2017-09-08)
- Starting date:
- September 8, 2017
- Posting date:
- October 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, Healthcare Professionals, General Public
- Identification number:
- RA-64742
Affected products
COATED VICRYL RAPIDE SUTURE
Reason
Manufacturer has identified that certain lots of sizes 2-0 and 4-0 for VICRYL RAPIDE Suture exhibited suture damage due to a manufacturing equipment issue. The manufacturing equipment issue has been corrected.
The medical assessment concluded that this situation could result in a potential superficial wound dehiscence or contribute to impaired wound healing but only occasionally and/or under unusual circumstances. Manufacturer has not received any reports of adverse events associated with the product subject to this recall.
Affected products
COATED VICRYL RAPIDE SUTURE
Lot or serial number
AH6611
AH7680
AH7686
AH7694
AH7711
AJ0770
AJ0794
Model or catalog number
VR2297
VR496
VR945
Companies
- Manufacturer
-
Ethicon Inc.
Rt. 22 West, P.O. Box 151
Sommerville
08876
New Jersey
UNITED STATES