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U.S. Department of Health and Human Services

Class 2 Device Recall PE CONNECTOR 3/8 STRAIGHT

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 Class 2 Device Recall PE CONNECTOR 3/8 STRAIGHTsee related information
Date Initiated by FirmApril 21, 2017
Create DateMay 22, 2017
Recall Status1 Terminated 3 on January 27, 2020
Recall NumberZ-2127-2017
Recall Event ID 77081
Product Classification Connector, catheter - Product Code GCD
ProductPE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Code Information Product Code: PE100, Lot numbers: 02F0801115, 02F0901859, 02G0802748, 02G0900814, 02H0900192, 02K0900567, 02L0900163, 02M0901006, 74A1601695, 74G1500137, 74G1502714 & 74M1400489.
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information ContactElizabeth Norwood
919-544-8000 Ext. 68487
Manufacturer Reason
for Recall		Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
FDA Determined
Cause 2		Labeling False and Misleading
ActionConsignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the Attn: Customer Service or email to recalls@teleflex.com. A Recall Acknowledgment Form was enclosed to be completed and returned via fax even if they have no stock.
Quantity in Commerce19,043 units in total
DistributionWorldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.
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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