FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9057 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
- Recall number
- Z-0157-2011
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9057 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
- 104,700 sets
- Distribution
- Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
- Lot, serial or model codes
- product 2N9057, lots UE104968, UE105502, UE106096, UE106369, UE106971, UE107029, UE107276, UE107318, UE107664, UE107672, UE107706, UE112565, UE112953, UE113118, UE113134, UE113258, UE103440, UE103457 and UE103465
- 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
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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