Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses
FDA device recall Z-0573-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.
- Action taken
- An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 786
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2014-11-10
- Date posted
- 2014-12-12
- Date terminated
- 2016-09-08
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (K121403) | Teleflex, Inc. | 2012-06-20 |