Baxa Repeater Pump Recall Issued for Contradictory Operator Manual Instructions
Baxa Corporation is recalling Repeater Pump models 095, 099, and 099R because the included Technical Manual contradicts the Operator Manual regarding multiple source container use.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is a documentation issue involving contradictory manuals, which falls under the 'Low' severity criterion for documentation issues and packaging-only problems.
Plain-English summary
Baxa Corporation is issuing a field correction for the Repeater Pump, a Class II medical device used in hospital pharmacies to facilitate repeatable drug dosage distribution and reconstitution. The recall affects models 095, 099, and 099R. The device is designed for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.
The recall was initiated because the Technical Manual was distributed with the device instead of the Operator Manual. These two documents contain contradictory instructions regarding the use of multiple source containers. The firm is correcting the documentation to ensure operators have the proper instructions.
The affected devices were distributed worldwide, including in the United States and countries such as Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, the UK, and Venezuela. Hospital pharmacies and users of these devices should verify their documentation and contact Baxa Corporation for the corrected manual.
The recalled product
- Product
- Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device…
- Manufacturer
- Baxa Corporation
- Hazard
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 (3)
- Repeater Pump model #s 095
- 099
- and 099R.
Distribution
Distributed nationwide across the United States.
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