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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0082-04
Recalling firm
Arrow International Inc
Product
Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm
Status
Terminated
Initiated
2003-09-16
Posted
2003-11-01
Terminated
2004-04-05
Reason
wrong product in box
Root cause
Other
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.
Quantity
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, IN, SC, and VA. The products were shipped to hospitals nationwide.
Lot, serial or model codes
Catalog number AK-25703, Lot number RF3066892
510(k) numbers
["K900263"]
PMA numbers
not on file
Product code
KZH
Firm FEI
3015859709
Firm city
Reading
Firm state
PA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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