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U.S. Department of Health and Human Services

Class 2 Device Recall BARD MYPICC Kit, REF CK000095B

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 Class 2 Device Recall BARD MYPICC Kit, REF CK000095Bsee related information
Date Initiated by FirmJanuary 12, 2018
Create DateJuly 06, 2018
Recall Status1 Terminated 3 on July 22, 2020
Recall NumberZ-2378-2018
Recall Event ID 80197
Product Classification Central venous catheter tray - Product Code OFF
ProductBARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
Code Information Lot 17YM5936, Exp. 04/30/2019
FEI Number 3000717925
Recalling Firm/
Manufacturer		 Medline Industries, Inc.
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactKassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		One of the cases of product might not have been sterilized.
FDA Determined
Cause 2		Process control
ActionThe recalling firm's sales representative telephoned their one customer on 1/12/2018 requesting return of the product.
Quantity in Commerce6/5-kit cases
DistributionThe product was distributed to UT.
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.
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