—#95692

Product

Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K884552
Affected lot / code info: Lot # RF0063961

Why it was recalled

Sterility may be compromised.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Nationwide Distribution: USA states including IL and LA.

Timeline

Recall initiated: 2010-11-11
Posted by FDA: 2011-02-01
Terminated: 2012-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95692. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.