Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or t
FDA device recall Z-2740-2016 · posted 2016-09-07 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Shipping carton labeling error.
- Action taken
- Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 690 kits
- Distribution
- Nationwide Distribution to OH, IN, TN, NC, and KY.
- Date initiated
- 2016-08-08
- Date posted
- 2016-09-07
- Date terminated
- 2017-08-22
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW RADIAL ARTERY CATHETERIZATION SET (K810675) | Arrow Intl., Inc. | 1981-03-27 |