Device product
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
Z-2957-2018
Product summary
- Event
- Event 80757
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46,908 pouches
- Official record key
device-enforcement:Z-2957-2018
Official wording
Reason: Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.
Code information: Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
Distribution pattern: Nationwide distribution to AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Australia, Korea, Taiwan, Columbia.
Derived failure modes
-
Unknown
Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.