Atlas FDA

Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm

FDA device recall Z-0082-04 · posted 2003-11-01 · Terminated

Recall details

Recalling firm
Arrow International Inc
Reason for recall
wrong product in box
Action taken
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
Status
Terminated
Product code
KZH
Quantity affected
4480 units
Distribution
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,
Date initiated
2003-09-16
Date posted
2003-11-01
Date terminated
2004-04-05
Location
Reading, PA

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Related 510(k) clearances

RecordFirmDate
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER (K900263)Arrow Intl., Inc.1990-07-24