—#94351

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K781036
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

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

Timeline

Recall initiated: 2010-09-09
Posted by FDA: 2010-10-27
Terminated: 2011-09-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94351. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.