Blue Rhino G2-Multi tracheostomy introducer trays carry overstated expiration dates
Cook Medical is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because affected lots were labeled with expiration dates that exceed the true shelf life. 441 units are affected.
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: FDA Class II recall where an overstated expiry date can lead to use of a sterile device beyond its validated shelf life, a risk of harm with no injuries reported.
Plain-English summary
Cook Medical is recalling the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, reference part numbers C-PTISY-100-HC-G-NA (order number G57703), C-PTISY-100-UNL-HC-G-NA (order number G57706) and C-PTISY-100-UNS-HC-G-NA (order number G57704). The action covers 441 units.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A tray carrying an overstated expiry can be held and used after the point at which its sterility and performance were validated. The FDA classified the action as Class II.
Distribution was worldwide. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the reference part numbers and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.
The recalled product
- Product
- COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number…
- Manufacturer
- Cook Incorporated
- Affected units
- 441
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 (19)
- Reference Part Number C-PTISY-100-HC-G-NA
- UDI (01)00827002577039(17)270730(10)16183353X
- Lot Number 16183353X
- UDI (01)00827002577039(17)270524(10)16076948
- Lot Number 16076948
- UDI (01)00827002577039(17)260222(10)15473203X
- Lot Number 15473203X
- UDI (01)00827002577039(17)260201(10)15476984X
- Lot Number 15476984X
- UDI (01)00827002577039(17)261020(10)15719188X
- Lot Number 15719188X
- Reference Part Number C-PTISY-100-UNL-HC-G-NA
- UDI (01)00827002577060(17)270814(10)16205108
- Lot Number 16205108
- Reference Part Number C-PTISY-100-UNS-HC-G-NA
- UDI (01)00827002577046(17)270528(10)16080161X
- Lot Number 16080161X
- UDI (01)00827002577046(17)270901(10)16435112
- Lot Number 16435112.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Cook Incorporated 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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