Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits pl
FDA device recall Z-0546-2014 · posted 2013-12-19 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
- Action taken
- The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 121
- Distribution
- Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
- Date initiated
- 2013-10-09
- Date posted
- 2013-12-19
- Date terminated
- 2015-09-21
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (K121403) | Teleflex, Inc. | 2012-06-20 |