Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural sp
FDA device recall Z-1012-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Sterility may be compromised.
- Action taken
- The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935. If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 2320
- Distribution
- Nationwide Distribution: USA states including IL and LA.
- Date initiated
- 2010-11-11
- Date posted
- 2011-02-01
- Date terminated
- 2012-07-05
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER (K884552) | Arrow Intl., Inc. | 1989-03-14 |