FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
- Recall number
- Z-0143-2014
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
- Status
- Terminated
- Initiated
- 2013-09-10
- Posted
- 2013-11-06
- Terminated
- 2015-06-05
- Reason
- The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.
- Root cause
- Employee error
- Action
- Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to : 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use.The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. Please have the product code and lot number(s) available. 4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013. The Center for One Baxter is available at 1-800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.
- Quantity
- 628,992 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Canada.
- Lot, serial or model codes
- 10043, 10044
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OBK
- Firm FEI
- 1417572
- Firm city
- Deerfield
- 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
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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