Cervical Tray Catalog Number: 3765R2
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Cervical Tray catalog number 3765R2 due to swab and swabstick products contained within the kits that were manufactured by Professional Disposables International (PDI). These products are subject to recall because there is uncertainty about whether the test methods used during manufacturing were adequately validated. The recalled kits were distributed nationwide, with 40 units affected across lot numbers 2031213S and 2130221S.
The source document does not specify what actions 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: 40 units Lot/code info: Lot Numbers: 2031213S 2130221S UDI: 00849233015203
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.