Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 888814504
FDA device recall Z-0329-2016 · posted 2015-11-24 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Incorrectly packaged with a 90 degree bend at the distal tip
- Action taken
- The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: feedback.customerservice@Covidien.com/Distributor to (203) 492-7719 or email to: PalCathFCA@Covidien.com. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NYU
- Quantity affected
- 280 units
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
- Date initiated
- 2015-10-14
- Date posted
- 2015-11-24
- Date terminated
- 2017-06-02
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH (K123196) | Covidien | 2013-01-31 |