FDA Medical Device Recalls (openFDA)
Covidien LLC: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
- Recall number
- Z-2601-2018
- Recalling firm
- Covidien LLC
- Product
- Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
- Status
- Terminated
- Initiated
- 2018-06-15
- Posted
- not on file
- Terminated
- 2019-05-08
- Reason
- Potential proplylene glycol contamination
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 972 units
- Distribution
- CA, NY & TX
- Lot, serial or model codes
- UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
- 510(k) numbers
- ["K981935"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28