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U.S. Department of Health and Human Services

Class 2 Device Recall Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS21

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 Class 2 Device Recall Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS21see related information
Date Initiated by FirmJune 15, 2018
Create DateAugust 03, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall NumberZ-2601-2018
Recall Event ID 80542
510(K)NumberK981935 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductPolysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Code Information UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
FEI Number 1219930
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-5000
Manufacturer Reason
for Recall		Potential proplylene glycol contamination
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAll 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 in Commerce972 units
DistributionCA, NY & TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GAM
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