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Class 2 Device Recall PE CONNECTOR 3/8 STRAIGHT |
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Date Initiated by Firm |
April 21, 2017 |
Create Date |
May 22, 2017 |
Recall Status1 |
Terminated 3 on January 27, 2020 |
Recall Number |
Z-2127-2017 |
Recall Event ID |
77081 |
Product Classification |
Connector, catheter - Product Code GCD
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Product |
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use,
Product Usage: Catheter Connector/Accessory
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Code Information |
Product Code: PE100, Lot numbers: 02F0801115, 02F0901859, 02G0802748, 02G0900814, 02H0900192, 02K0900567, 02L0900163, 02M0901006, 74A1601695, 74G1500137, 74G1502714 & 74M1400489. |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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For Additional Information Contact |
Elizabeth Norwood 919-544-8000 Ext. 68487
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Manufacturer Reason for Recall |
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
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FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Consignees 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 Commerce |
19,043 units in total |
Distribution |
Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea. |
Total Product Life Cycle |
TPLC Device Report
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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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