Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
This recall has been terminated (originally issued June 15, 2018).
- Company
- Covidien Llc
- Recall Initiated
- June 15, 2018
- Terminated
- May 8, 2019
- Recall Number
- Z-2601-2018
- Quantity
- 972 units
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential proplylene glycol contamination
Distribution
CA, NY & TX
Lot / Code Info
UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
Root Cause
Nonconforming Material/Component
Action Taken
All U.S. consignees were notified via Federal Express or certified mail on June 15, 2018, and the letter informs customers of the potential that the suture was contaminated with propylene glycol during the manufacturing process and the actions they should take. Customers are advised to discontinue use of the product and return all inventory of the affected lot to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
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