Airway and neuro procedure kits recalled over cracking adhesive tubing
Medline is recalling 857 units of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
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: Scored 2 because the record cites a supplier component recall over cracking tubing with no stated consequence or reported harm.
Plain-English summary
Medline medical procedure convenience kits are being recalled by Medline Industries, LP, covering Drawer 1 Airway under Medline kit SKU ACC010270A, Drawer 2 under SKU ACC010690, Drawer 3 Syr/Drs/Mon/NG 1 of 3 under SKU ACC011073, the Hypospadius Pack under SKU DYNJ00282Q and the SJ Neuro Pack, among the kits listed in the enforcement record.
The record states the Medline kits were manufactured and distributed containing MASTISOL liquid adhesive, which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
The record lists 857 units, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- Product
- Black Bean Bonanza Tamales with Black Beans NO DAIRY Ingredients: Organic Corn Flour Masa, Black Beans, Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Non-GMO Corn, Non-hydrogenated Vegetable Shortening, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarb
- Manufacturer
- Prima Vera Nueva, Inc.
- Category
- Medical Device — Procedure kit
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 (1)
- UPC: 748732000287
Distribution
Part of a larger recall action
This product is one of 10 recalled by Prima Vera Nueva, Inc. under a single FDA (Food) 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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