Teleflex Recalls Rusch EasyCath Kits Due to Sterility Concerns
Teleflex Medical is recalling 3,700 Rusch EasyCath Kits because they may not be sterile. The kits were distributed nationwide to eight states.
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 hazard involves a potential loss of sterility in a medical device, which poses a risk of harm even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 3,700 units of the Rusch EasyCath Kit. The recall was initiated because there is a potential for the product not to be sterile. The affected devices are identified by Catalog Number ECK120, Lot Number 74C1900304, Expiration Date 03/01/2022, and Catalog Number ECK125, Lot Number 74B1901676, Expiration Date 06/01/2022.
The affected kits were distributed nationwide to California, Florida, Illinois, North Carolina, New Jersey, Ohio, Oklahoma, and Texas. The source text does not specify the exact number of affected units in each state or the specific facilities where they were distributed.
Consumers and healthcare providers should check their inventory for the specific catalog and lot numbers listed above. If the product matches the recalled items, it should be removed from use. The source text does not provide specific instructions for disposal or return, so users should contact Teleflex Medical or their local FDA office for further guidance.
The recalled product
- Product
- Rusch EasyCath Kit
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Catheter Kits
- Affected units
- 3,700
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 (5)
- Catalog Number ECK120
- Lot Number 74C1900304
- Expiration Date 03/01/2022. Catalog Number ECK125
- Lot Number 74B1901676
- Expiration Date 06/01/2022.
Distribution
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