FLOSEAL Special Applicator Tips in cartons labeled in recall
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The…
Why was FLOSEAL Special Applicator Tips in cartons labeled in recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384
- Product
- FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 46,908 pouches
- Distribution
- 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.
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)