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FDA Medical Device Recalls (openFDA)

Baxa Corporation: Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.

Recall number
Z-2165-2013
Recalling firm
Baxa Corporation
Product
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
Status
Terminated
Initiated
2013-08-22
Posted
2013-09-06
Terminated
2016-08-19
Reason
Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.
Root cause
Labeling Change Control
Action
An Urgent Product Recall notification was mailed to one customer via USPS First Class mail on 8/22/13. The one customer affected by this action was instructed to locate and remove the affected product from inventory and to return to Baxter for credit and/or replacement. Any customer returns received will be discarded per the Corporate Hold.
Quantity
34 cases
Distribution
Distributed to One Customer in NC.
Lot, serial or model codes
Lot or Serial No. 785518
510(k) numbers
["K900585"]
PMA numbers
not on file
Product code
LHI
Firm FEI
1419106
Firm city
Englewood
Firm state
CO
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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