Recalls / —

—#34583

Product

Peritoneal Lavage Kits, Model number AK-09000

FDA product code

GBW — Catheter, Peritoneal

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K811627

Affected lot / code info

Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06, RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp. 8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06, RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592 exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp. 12/06.

Why it was recalled

wrong introducer needle in some kits

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.

Timeline

Recall initiated

2004-08-02

Posted by FDA

2004-08-25

Terminated

2005-08-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.