B. Braun Shands kits contain Mastisol adhesive with cracking tubing
B. Braun CESK Shands Jacksonville kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering the product unusable.
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. CESK Shands Jacksonville kit, model/catalog number 555884, is being recalled. The action covers 680 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 kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits 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: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Procedure kit
- Affected units
- 680
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 555884
- UDI-DI (Primary Device) 04046964317361
- UDI-DI (Unit Device ID) 04046964317347
- Lot Number 0062036271
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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