I.V. Start Kit Catalog 8172
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling I.V. Start Kit Catalog 8172 (Busse Convenience kits) due to a safety concern involving swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall stems from uncertainty about whether the test methods used to validate the manufacture of these drug products were adequate. The affected kits were distributed nationwide, with 4,218 units involved. Specific lot numbers identified in the recall are 2020561, 2020560, 2020650, 2120089, 2120018, 2120344, 2120442, 2120645, 2120768, and 2120911.
The source document does not specify a remedy or recommended action for consumers who have the affected product.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Nationwide Quantity: 4218 units Lot/code info: Lot Numbers: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 00849233015883
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.