SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 3.5MM Diamond Tip Trocar - Medium Gloves (Catalog Number B1555) sold as Convenience kits. The kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall was issued due to uncertainty about whether the test methods used to validate these drug products during manufacturing were adequate.
The recalled products were distributed nationwide, with 60 units affected. The specific lots involved are Lot Numbers 2110053 and 2110115. The recall 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: 60 units Lot/code info: Lot Numbers: Lot 2110053 2110115 UDI: 00849233005402
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.