Recalls / —

—#165710

Product

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

FDA product code

GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K981935

Affected lot / code info

UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X

Why it was recalled

Potential proplylene glycol contamination

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Covidien LLC

Address

60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern

CA, NY & TX

Timeline

Recall initiated

2018-06-15

Terminated

2019-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #165710. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.