Medline Semi-Rigid Suction Canister Lid Recall for Fragmentation Risk
Medline Industries is recalling Semi-Rigid Suction Canisters because the lids may fragment during use, posing a risk to patients and healthcare workers.
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 with a risk of harm (fragmentation) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc is recalling 750 units of Semi-Rigid Suction Canisters, 3000cc, Model Numbers OR530 and OR530H. The recall is due to a potential for the canister lid to fragment during use.
The affected products were distributed nationwide to facilities in 31 states, including Alabama, Arizona, California, and Texas. The specific lot numbers involved are 20180914-1, 20180913-1, 20180916-1, and 20180929-1.
Healthcare facilities should stop using the affected canisters and contact Medline Industries for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the…
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 750
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 (6)
- Model Numbers OR530
- OR530H
- Lot Numbers 20180914-1
- 20180913-1
- 20180916-1
- 20180929-1
Distribution
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