Teleflex Medical Recalls Pluer-evac Sahara Chest Drainage Systems
Teleflex Medical is recalling 2,148 adult-sized Pluer-evac Sahara Chest Drainage Systems because they contain infant-sized components.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the risk of using an infant-sized medical device on an adult.
Plain-English summary
Teleflex Medical is recalling 2,148 units of the Pluer-evac Sahara Chest Drainage System, model S-1100-08LF. The recall was initiated because the adult-sized product packages contain infant-sized chest drainage systems. The affected units are identified by Catalogue no. S-1100-08LF and Lot no. 74F1400878.
The recalled products were distributed in the United States to the states of AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA, WI, and WV. The FDA has classified this recall as Class II.
Healthcare providers and patients should stop using the affected devices and contact Teleflex Medical for instructions on how to return or replace the product.
The recalled product
- Product
- Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Chest Drainage
- Affected units
- 2,148
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)
- Catalogue no. S-1100-08LF
- Lot no. 74F1400878
Distribution
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