Baxter Healthcare Corp.: Baxter Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9051 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

Recall number

Z-0154-2011

Recalling firm

Baxter Healthcare Corp.

Product

Baxter Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9051 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

Status

Terminated

Initiated

2010-09-09

Posted

2010-10-27

Terminated

2011-09-07

Reason

During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.

Root cause

Package design/selection

Action

Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Quantity

498,850 sets

Distribution

Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.

Lot, serial or model codes

product 2N9051, lots UE105130, UE105247, UE105437, UE105478, UE106237, UE106245, UE106351, UE106435, UE106443, UE106450, UE106682, UE106989, UE106823, UE106831, UE106914, UE106963X, UE107086, UE107243, UE107250, UE107235, UE107334, UE107342, UE107359, UE107383, UE107649, UE107656, UElO7755, UE107771, UE107896, UEl07946, UE108175, UE108258, UE108431, UE108472, UE108605, UE108621, UE108647, UE108654, UE108803, UE108837, UE108910, UE109058, UE109074, UE109298, UE109306, UE109322, UE109520, UE109777, UE109801, UE109835, UE110023, UE110627, UE110734, UE110908, UE110957, UE111278, UE111484, UE112524, UE112532, UE112938, UE112946, UE113035, UE100420, UE100925, UE101097, UE101097X, UE10l113, UE101113X, UE101170, UE101477, UE102202, UE102202T, UE102756, UE102962, UE103309, UE103622, UE103630, UE103648, UE103705, UE104133, UE104182X, UE104257, U505883, U546168, U551820 and U585687

510(k) numbers

["K964918"]

PMA numbers

not on file

Product code

FPA

Firm FEI

1416980

Firm city

Round Lake

Firm state

IL

Firm country

not on file

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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