Baxter Recalls RAPIDFILL Syringe Strips Due to Sterile Barrier Breach
Baxter Corporation is recalling RAPIDFILL Syringe Strips because of a possible breach in the sterile barrier of the inner and outer bags.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterile barrier breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Corporation is recalling specific lots of RAPIDFILL Syringe Strips, which are sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material. These products are intended for use with the RAPIDFILL Automated Syringe Filler (ASF).
The recall is being issued due to a possible breach in the sterile barrier for the inner and outer bags of the product. This defect could potentially compromise the sterility of the syringes.
The affected products were distributed worldwide, including in the United States and Canada. Specific US states listed in the distribution pattern include AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV, and WI. Healthcare facilities and users should check their inventory for the specific product codes and lot numbers listed in the official recall notice and stop using any affected units.
The recalled product
- Product
- RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe…
- Manufacturer
- Baxter Corporation Englewood
- Category
- Medical Device — Syringes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Product Code: H93890200 Lots 787032 to 790790
- Codes H93890221 Lots 789096 to 791247
- Code H93890222 Lots 787761 to 790791
- Code H93890223 Lots 786926 to 789793
- Code H93890225 Lots 789794 to 790792
- Code H93890227 Lots 789098 to 791246
- Code H93890229 Lots 789637 to 790794
- Code H93890231 Lots 788465 to 790795
- Code H93890232 Lots 790796 to 791245
Distribution
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