Z-0152-2011

Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile...

Name: Z-0152-2011 Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile...
Creator: Baxter Healthcare Corp.
Published: 2010-09-09
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2010-09-09 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL... on 2010-09-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0152-2011
Status: Terminated
Initiated: 2010-09-09
Posted: 2010-10-27
Terminated: 2011-09-07
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 1M8450 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Product code: FPA Set, Administration, Intravascular
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 17,356 sets
Distribution: Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
Product codes and lots: product 1M8450, lots UR135053, UR145201, UR153098, UR170324, UR195305, UR200162, UR101642, UR104034, UR108837, U383174R, U384651R, U384727R, U390344R, U417055R, U417170R, U417295R, U429340R, U438515R, U447201R, U458000R, U462036R, U467787R, U480632R, U484618R, U488163R, U493742R, U500074R, U502997R, U503607R, U509752R, U511329R, U517870R, U518068R, U523753R, U526434R, U528224R, U534131R, U537779R, U542944R, U544288R, U548446R, U554519R, U560342R, U560599R, U569608R, U582635R and U587568R

Product code FPA

K781036Class IIAuto-Syringe Infusion SetBaxter Healthcare Corp / cleared 1978-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)