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HeliTape Absorbable Collagen Wound Dresssing andHeliPLUG Absorbable Collagen Wound Dressing (2013-06-03)
- Starting date:
- June 3, 2013
- Posting date:
- October 10, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41743
Recalled Products
A) HeliTape Absorbable Collagen Wound Dresssing
B) HeliPLUG Absorbable Collagen Wound Dressing
Reason
Due to process deviation, the affected product lots may have been released with higher levels of endotoxins than permitted by the specifications for the product.
Affected products
A) HeliTape Absorbable Collagen Wound Dresssing
Lot or serial number
1110250
1110252
1110551
1111365
1111878
Model or catalog number
62-200
Companies
- Manufacturer
-
Integra York Pa, Inc.
589 Davies Drive
York
17402
Pennsylvania
UNITED STATES
B) HeliPLUG Absorbable Collagen Wound Dressing
Lot or serial number
1104622
1104962
1110241
1110242
1110264
1110783
Model or catalog number
62-202
Companies
- Manufacturer
-
Integra York Pa, Inc.
589 Davies Drive
York
17402
Pennsylvania
UNITED STATES