Pain Tray Catalog Number: 9883
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Pain Tray Catalog Number 9883, which contains convenience kits with swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall was initiated because there is uncertainty about whether the test methods used to manufacture these drug products were properly validated. A total of 421 units were distributed nationwide across multiple lot numbers.
The record does not specify what action affected consumers should take in response to this recall.
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: 421 units Lot/code info: Lot Numbers: 2031092 2130020 2130288 2130670 2130020 2130905 2131181 2131317 UDI: 00849233012158
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.