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U.S. Department of Health and Human Services

Class 2 Device Recall Busse Lumbar Tray

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  Class 2 Device Recall Busse Lumbar Tray see related information
Date Initiated by Firm February 22, 2022
Create Date May 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1150-2022
Recall Event ID 90072
Product Classification Manometer, spinal-fluid - Product Code FMJ
Product Lumbar Tray
Catalog 1091
Code Information Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 00849233000247
Recalling Firm/
Manufacturer		 Busse Hospital Disposables, Inc.
75 Arkay Dr
Hauppauge NY 11788-3707
Manufacturer 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
FDA Determined
Cause 2		 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 PDIrecall@busseinc.com 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 PDIrecall@busseinc.com. 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 330 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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