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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH

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 Class 2 Device Recall RUSCHsee related information
Date Initiated by FirmNovember 22, 2016
Create DateDecember 16, 2016
Recall Status1 Terminated 3 on November 24, 2017
Recall NumberZ-0771-2017
Recall Event ID 75781
510(K)NumberK010420 
Product Classification Catheter, urological - Product Code KOD
ProductRUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Code Information Product Code: 10096080, Lot number: 74F1501853 (8 FR); Product Code: 10096120, Lot numbers: 74E1602795, 74F1503201, 74G1600723 & 74J1500576 (12 FR); Product Code: 10096140, Lot numbers: 74A1600023, 74A1601105, 74A1602234, 74D1602007, 74E1602235, 74E1602796, 74F1501855, 74G1600486, 74H1500530 & 74L1500363 (14 FR); Product Code: 10096100, Lot numbers: 74A1600799, 74A1600800, 74A1602236, 74A1603122, 74D1600231, 74D1600923, 74D1601540, 74D1602136, 74E1600845, 74E1601768, 74E1602237, 74F1501857, 74F1501962, 74F1601966, 74F1601988, 74H1500534, 74H1500978, 74J1501157, 74K1502306, 74L1500364, 74L1501303, 74L1501938, 74M1500227 and 74M1501087 (10 FR) and Product Code: 10096160, Lot numbers: 74A1600024, 4A1600801, 74A1601106, 74A1603123, 74D1601541, 74E1600846, 74E1602797, 74G1600724, 74H1500979, 74J1501158, 74K1501837, 74L1501202 &74L1501939 (16 FR). 
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information ContactAlice Harper
610-378-0131
Manufacturer Reason
for Recall		Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
FDA Determined
Cause 2		Error in labeling
ActionTeleflex sent an Urgent Medical Device Recall Notification letter dated November 22, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers with affected stock, immediately discontinue use and quarantine any affected products. To return product, customers were advised to complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recall@teleflex.com. Customers with no affected stock should also complete the enclosed Recall Acknowledgment Form to confirm receipt of the letter. Customers with questions should contact Customer Service at 1-866-246-6990.
Quantity in Commerce102,843 units
DistributionNationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and 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 = KOD
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