Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging
Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.
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: The recall is classified as FDA Class II. The hazard is a potential for contamination due to packaging defects, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Elcam Medical, Inc. is recalling the MANI 3G Plate BLS RAD B.BRAUN, a manifold for pressure monitoring and intravenous fluid administration. The device is manufactured by Elcam Medical ACAL in Israel and distributed by Elcam Medical Inc. in the United States. The recall involves 248,100 units distributed to Texas, New Mexico, and Pennsylvania.
The recall was initiated because punctured blister packages were detected during the packaging process at the manufacturing site. This defect creates a potential for device contamination, as the sterile packaging integrity is compromised.
Healthcare facilities and consumers who have these specific devices should stop using them and contact Elcam Medical, Inc. for further instructions. The affected units are identified by specific Elcam Part Numbers and lot numbers listed in the official recall documentation.
The recalled product
- Product
- Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
- Manufacturer
- Elcam Medical, Inc.
- Affected units
- 248,100
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 (20)
- Elcam Part Number: 470306
- lot numbers: 1370256602
- 1370263901
- 370263902
- 1370271301
- 1370274101
- 1470288601
- 1470288602
- 1470298801
- 1470306701
- 1470312401 Elcam Part Number: 470307
- lot numbers: 1370254802
- 1370266801
- 370271401
- 1370282101
- 1470288701
- 1470293001
- 1470295901 Elcam Part Number: 471601
- lot numbers: 1270239001
- 1370266601
Distribution
Part of a larger recall action
This product is one of 2 recalled by Elcam 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.
See all 2 products in this recall →Related recalls
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