Z-1194-2022Class II
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Busse Hospital Disposables / initiated 2022-02-22 / Terminated / root cause: manufacturing process
Busse Hospital Disposables, Inc. began a recall of Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1194-2022
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Busse Hospital Disposables
- Product
- Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
- Product code
- FBQ Trocar, Gastro-Urology
- 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
- Root cause tag
- manufacturing process
- FDA root cause
- Other
- Action
- Busse Hospital Disposables issued Product Recall Notification on 2/22/22 Re: PDI Prevantics Swab, Swabstick, and Maxi Swabstick Voluntary Recall stating reason for recall , health risk and action to take: Busse Hospital Disposables has initiated a voluntary recall on any products containing the affected product. However, it is important to note the integrity of the kit and other components is not compromised by the recalled PDI prevantic pouches. PDI shipped this product between February 2020 and July 2021. Please take the following actions: 1. Immediately check your inventory for the lots listed above. 2. Cease distribution and/or use of the product with the lot number(s) listed above. 3. Complete the enclosed Response Form within the next 10 days and return via email to [email protected] even if you have no affected product on hand. 4. Busse will then issue Return Goods authorization(s) to allow for product to be returned. ***Update: Firm issued a 2nd notification on 03/25/2022, as recall is extended to the user-level. Letter states: Please note that the integrity of the kit and other components are not compromised by the recalled PDI Prevantic pouches. Therefore, the kits affected may continue to be used without the PDI Prevantics Swab/Swabsticks. 1. Immediately check your inventory for the Busse kit lot numbers listed above. 2. Complete the enclosed Response Form specifying the quantity available in your stock within the next 10 days and return via email to [email protected]. If there is no Busse kits affected in your possession, please return the form noting this as well. 3. Cease use of the PDI Prevantics pouches in the Busse kits with lot number(s) listed above and discard once the kit is used/opened. An alternative skin prep swab at your disposition should be used for the procedure.
- Quantity in commerce
- 100 units
- Distribution
- Nationwide
- Product codes and lots
- Lot Numbers: 2130338 2130562 UDI: 00849233005525
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1147-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1148-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1149-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1150-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1151-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1152-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1153-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1154-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1155-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1156-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1157-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1158-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1159-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1160-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1161-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1162-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1163-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1164-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1165-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1166-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1167-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1168-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1169-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1170-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1171-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1172-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1173-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1174-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1175-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1176-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1177-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1178-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1179-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1180-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1181-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1182-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1183-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1184-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1185-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1186-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1187-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1188-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1189-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1190-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1191-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1192-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1193-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1194-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1195-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1196-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1197-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1198-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1199-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1200-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1201-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1202-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1203-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1204-2022 | Class II | Terminated | Voluntary: Firm initiated |
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