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U.S. Department of Health and Human Services

Class 2 Device Recall Pilling COOLEY SUMPSUCTION TUBE

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  Class 2 Device Recall Pilling COOLEY SUMPSUCTION TUBE see related information
Date Initiated by Firm January 07, 2019
Create Date February 16, 2019
Recall Status1 Terminated 3 on November 04, 2021
Recall Number Z-0846-2019
Recall Event ID 81918
Product Classification Catheter and tip, suction - Product Code JOL
Product Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Code Information Lot/Batch Numbers: A8, C8, I7
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
Manufacturer Reason
for Recall		 The internal tip is missing from the device, causing the device to not function as intended.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm initiated the recall by letter on 01/07/2019. The firm requested the return of the units.
Quantity in Commerce 80 units
Distribution TX, NY, DC and Philippines
Total Product Life Cycle TPLC 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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