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Terminated

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.

FDA Recall Z-2165-2013 · Posted 2013-09-06

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeLHI
Date Initiated2013-08-22
Date Terminated2016-08-19
Product Quantity34 cases

Reason for Recall

Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed to One Customer in NC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPBaxa Corp., Sub. of Cook Group, Inc. · 1990-04-18

Official Source

View FDA Recall →

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

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