# FDA recall Z-2957-2018

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2018-05-30.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2957-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-30
- **Report date:** 2018-09-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2957-2018

## Citation

> AI Analytics. FDA recall Z-2957-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2957-2018. Source: US FDA. Licensed CC0.

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