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Terminated

Peritoneal Lavage Kits, Model number AK-09000

FDA Recall Z-1408-04 · Posted 2004-08-25

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeGBW
Date Initiated2004-08-02
Date Terminated2005-08-22
Product Quantity9100 units

Reason for Recall

wrong introducer needle in some kits

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K811627ARROW PERITONEAL LAVAGE CATHERIZATION KArrow Intl., Inc. · 1981-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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