B. Braun BlockJocks trays contain Mastisol adhesive with cracking tubing
B. Braun BlockJocks Trays are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable. 210 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the described consequence is that the component becomes unusable rather than any patient hazard, which fits the Moderate band.
Plain-English summary
The B. Braun Medical Inc. BPSK, BlockJocks Tray, model/catalog number 570246, is being recalled. The action covers 210 units.
B. Braun was notified by its supplier, Ferndale Laboratories, Inc., the manufacturer of Mastisol Liquid Adhesive, that Ferndale has issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. The FDA classified the action as Class II. The source does not describe any patient hazard beyond the product being unusable.
Distribution was within the United States, in Alabama, Florida, Pennsylvania, Texas, Virginia and Washington. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number and UDI-DI codes in the recall notice and follow the instructions issued by B. Braun.
The recalled product
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Procedure kit
- Affected units
- 210
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Code: Model No 570246
- UDI-DI (Primary Device) 04046964526688
- UDI-DI (Unit Device ID) 04046964526671
- Lot Number 0062024481
Distribution
Part of a larger recall action
This product is one of 8 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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