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Terminated

ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

FDA Recall Z-0132-2016 · Posted 2015-10-16

Recalling FirmBaxter Healthcare Corp
Recall StatusTerminated
Product CodeFPA
Date Initiated2015-05-21
Date Terminated2017-05-10
Product Quantity23,600

Reason for Recall

Potential for a leak at the tubing to luer bond.

Firm Action

Baxter sent their consignees a recall letter dated 05/21/2015 with the following instructions: Actions to betaken if product was purchased directly from Baxter : 1. Locate and remove all affected product from your 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. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number(s) and quantity of product to be returned ready when calling. 3. Complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected] . Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 4. If you distribute this product to other facilities or departm ents within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or Original Equipment Manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. Action to be taken if product was purchased from a distributor: 1. Locate and remove all affected product from your 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. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00pm central time, Monday through Friday. 3. Pl ease note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to the

Root Cause

Packaging

Distribution Pattern

Domestic Only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSBaxter Healthcare Corp · 2013-10-08

Official Source

View FDA Recall →

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

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