International Life Sciences: Artelon FlexBand Plus Ref: 41054 & 41057

Hazard

Augmentation devices failed bacterial endotoxin testing.

Details from the source

Reason for recall: Augmentation devices failed bacterial endotoxin testing. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia. Quantity: N/A Lot/code info: REF: 41054 -Lot: A10010201/GTIN: 00850003396064 REF: 41057 - Lot: A10010101/GTIN: 00850003396033

UPC codes

00850003396064, 00850003396033

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.