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ONE-LINK recallZ-1102-2021 · Baxter Healthcare Corporation · initiated Dec 21, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

FDA root cause category: Process design

What the company is doing

The firm initiated the recall by email on 12/21/2020. The letter requested the following: 1. Locate and remove the affected product from consignee's facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Confirm the receipt of the letter by completing the enclosed Baxter customer reply form and return it to Baxter via email

Recall details

Recall number
Z-1102-2021
Status
Terminated
Initiated by the company
Dec 21, 2020
Recalling firm
Baxter Healthcare Corporation
Quantity
66,800 units
Product code
FPA
FDA submissions
K132734
Distribution
Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.

Product description

Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use.

Code information (models, lots, serial numbers)

UDI: 00085412613505, Lot Numbers: DR18E01023, exp. 5/2/2023; DR18E07053, exp. 5/8/2023; DR19G08023, exp. 7/8/2024; DR19H07015, exp. 8/7/2024; DR19L09030, exp. 12/10/2024; DR20B04020, exp. 2/5/2025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

12 devices cleared under K132734 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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