Busse Hospital Disposables recalls Pump Refill Kit (Catalog 7347R1) due to uncertain drug validation methods. Affected units include specific lot numbers. Consumers should contact for details.
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Busse Hospital Disposables is recalling Pump Refill Kit Catalog Number 734:7R1 because drug manufacturing validation methods are uncertain. This could affect product safety, though no injuries have been reported.
The drug products in the kit were manufactured using test methods that may not have been properly validated. This uncertainty could lead to unsafe drug products if the validation process failed to ensure quality.
Healthcare professionals using the Pump Refill Kit for drug administration are most at risk. Patients receiving these drugs may also be affected if the kit is used improperly.
Check for Catalog Number 7347R1 on the kit. Affected lots include 2030921 and 2130507. The Unique Device Identifier (UDI) is 00849233009363.
Reach out to Busse Hospital Disposables for specific instructions on handling affected units.
The recall is due to uncertainty in drug validation methods, but no injuries have been reported. The manufacturer considers it a safety concern.
Contact Busse Hospital Disposables directly for specific instructions on handling affected units.
Lot numbers 2030921 and 2130507 are affected.
We’ve drafted a message you can send Busse Hospital Disposables to request your refund or repair — edit it as you like.
Subject: Recall Z-1173-2022 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-1173-2022 from Busse Hospital Disposables. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.