Puritan Absorbent Foam Tipped Applicator Recall Due to Shaft Breakage
Puritan Medical Products is recalling sterile absorbent foam tipped applicators because the shafts may break, preventing adequate patient specimen collection.
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 is classified as FDA Class II, and the defect prevents adequate specimen collection, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Puritan Medical Products Co., LLC is recalling 9 cases of 500 sterile absorbent foam tipped applicators each. The product, identified by Catalog Number 25-1406 1 PF BT, Lot Number 3111, and an expiration date of 2016/04, is used to apply medication or obtain specimens from patients.
The recall is being issued because the applicator shafts may break, which prevents the collection of an adequate patient specimen sample. This defect compromises the intended use of the medical device.
The affected units were distributed in the states of Mississippi, Maine, Georgia, and North Carolina. Healthcare facilities and consumers who possess these specific applicators should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
- Manufacturer
- Puritan Medical Products Co., LLC
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)
- Lot Number 3111
- Expiration date: 2016/04
Distribution
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