FLOSEAL Special Applicator Tips in cartons labeled in part — Class II medical device recall Z-2957-2018
Ongoing recall by Baxter Healthcare Corporation, reported 2018-09-05, distributed nationwide. Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blu
| Recall number | Z-2957-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-05-30 |
| Classified | 2018-08-30 |
| Reported by FDA | 2018-09-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, KR, TW |
| Quantity | 46,908 pouches |
| Lot numbers | GR338160, GR338384, HA170718, HA170818, HA170917 |
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***"."
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2957-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.