Avid Medical Recalls Adult Heart Tray Shands Jacks Due to Lubricant Contamination
Avid Medical, Inc. is recalling 59 units of Adult Heart Tray Shands Jacks (Model SHND419-08) because they may be contaminated with a lubricant used during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Class II because the product may be contaminated with a lubricant used during manufacturing. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Avid Medical, Inc. is recalling 59 units of Adult Heart Tray Shands Jacks, Model/Item Number (Kit) SHND419-08. The recall is being conducted because the product may be potentially contaminated with a lubricant used during the manufacturing process.
The affected kits have UDI-DI 10809160502389 and include Kit Lot Numbers 1680504 and 1695337. The recalled supplier component within the kits is A319514AM, with supplier lot numbers NGKW2687 and NGKV2393.
The product was distributed nationwide in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 59
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 (7)
- 1. Model/Item Number (Kit): SHND419-08
- UDI-DI: 10809160502389
- Kit Lot Numbers: 1680504
- 1695337
- Recalled Supplier Component (in kit): A319514AM
- Recalled Supplier Lot Number (in kit): NGKW2687
- NGKV2393
Distribution
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