Canadian Hospital Specialties Recalls Polyurethane Feeding Tubes Due to Connector Detachment
Canadian Hospital Specialties is recalling specific lots of MED-RX polyurethane feeding tubes because the connector may detach from the tube.
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: The recall involves a medical device defect (connector detachment) that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Canadian Hospital Specialties is recalling 2,870 units of MED-RX polyurethane feeding tubes. The recall covers six specific reference numbers and lot combinations, including 5Fr, 6.5Fr, and 8Fr sizes in various lengths. The affected units were distributed in Georgia and Tennessee.
The recall was initiated after the firm received a complaint that the connector detached from the feeding tube. This defect presents a risk of harm to patients using the devices for feeding purposes.
Consumers and healthcare facilities should stop using the affected feeding tubes immediately. Users should check their inventory for the specific reference numbers and lot numbers listed in the recall notice. Those with questions regarding the recall should contact Canadian Hospital Specialties.
The recalled product
- Product
- MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
- Manufacturer
- Canadian Hospital Specialties
- Category
- Medical Device — Feeding Tubes
- Affected units
- 2,870
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 (14)
- a) 5Fr X 16" (40cm)
- REF 54-1650R
- Lot Number 141487 b) 6.5Fr X16" (40cm)
- REF 54-1665R
- Lot Number 141863 c) 5Fr X 24" (60cm)
- REF 54-2450R
- Lot Numbers: 142844
- 143130 d) 6.5Fr X 24" (60cm)
- REF 54-2465R
- Lot Number 142843 e) 8Fr X 24: (60cm)
- REF 54-2480R
- Lot Number 142870 f) 8Fr X 36" (91cm)
- REF 54-3680R
- Lot Number 142842
Distribution
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