Teleflex Recalls Pilling Cooley Sump-Suction Tubes Due to Missing Tip
Teleflex Medical is recalling 80 units of Pilling Cooley Sump-Suction Tubes because a missing internal tip prevents the device from functioning as intended.
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 that fails to function as intended, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Teleflex Medical is recalling 80 units of Pilling Cooley Sump-Suction Tubes, Reference 351547. The recall involves specific lot numbers A8, C8, and I7.
The recall was initiated because the internal tip is missing from the device, which causes it to not function as intended. The affected units were distributed to Texas, New York, the District of Columbia, and the Philippines.
Healthcare providers and consumers should stop using these devices and contact Teleflex Medical for further instructions or a replacement.
The recalled product
- Product
- Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 80
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 (3)
- Lot/Batch Numbers: A8
- C8
- I7
Distribution
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