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Recall Observatory FDA recall evidence

Device product

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

Z-1027-2019

February 04, 2019

Class II

Product summary

Firm
CP Medical Inc
Event
Event 82197
Status
Ongoing
Classification
Class II
Quantity
1,905 boxes (22,860 sutures total)
Official record key
device-enforcement:Z-1027-2019

Official wording

Reason: Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

Code information: Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)

Distribution pattern: Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.