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Terminated

Arrow central venous catheterization kit, 14 ga x 20 cm

FDA Recall Z-0083-04 · Posted 2003-11-01

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeKZH
Date Initiated2003-09-16
Date Terminated2004-04-05
Product Quantity240 units

Reason for Recall

wrong product in box

Firm Action

The recalling firm issued a recall letter to their direct customers dated 9/16/03. The recall letter explained the reason for recall and to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors in AL, AZ, CA, CO, FL, HI, IL, IN, KS, MD, MI, MN, MO, NC, NM, NY, OH, PA, TN, TX, VA, and WI. The products were shipped to government accounts in AZ, AK, DC, IN, SC, and VA. The products were shipped to hospitals nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc. · 1986-08-25

Official Source

View FDA Recall →

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

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