Surgical Tracheostomy Kit Recalled Due to Perforated Outer Wrapping Compromising Sterility
Medline Industries has recalled 120 units of Centurion Medical Products Tracheostomy Tray due to a perforated outer bag that prevents the exterior from remaining sterile, though the kit contents remain sterile.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a sterility assurance defect in surgical kits with no reported illnesses or injuries. The perforated outer bag creates a potential contamination risk during use, meeting the High severity criterion for risk-of-harm products without reported harm.
Plain-English summary
Medline Industries is recalling Centurion Medical Products Tracheostomy Tray kits (Reorder Number TC7470, Lot #22GME959) distributed nationwide. The recall affects 120 units of this surgical convenience kit.
The recall is due to perforations in the outer bag. These perforations prevent the exterior wrapping from remaining sterile, meaning only the contents inside the kit wrapping can be considered sterile. This compromises the intended sterility assurance of the product.
The recalled product
- Product
- Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 120
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 (2)
- GTIN 40653160116531
- Lot # 22GME959
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 20 products in this recall →Related recalls
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