Micromedics FibriJet Endoscopic Catheter Introducer Recalled for Packaging Seal Defects
Micromedics, Inc. is recalling 273 units of FibriJet Endoscopic Catheter Introducers because small channels in the sterile packaging seal may compromise package integrity and sterility assurance.
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 risk-of-harm product (sterile medical device) where the defect may affect sterility assurance, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Micromedics, Inc. is recalling 273 units of the Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. The affected devices were sterilized using Ethylene Oxide and are identified by Lot Number 163010 with an expiration date of June 2021.
The recall was initiated because the sterile packaging may contain small channels in the seal of the pouch. If these channels are present, the package integrity may be compromised, which may affect sterility assurance. The devices were distributed to facilities in Alabama, California, Florida, Mississippi, North Carolina, New Jersey, New York, Tennessee, and Texas, as well as to Israel.
Healthcare facilities should stop using the affected devices and contact Micromedics, Inc. for further instructions on the recall.
The recalled product
- Product
- Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
- Manufacturer
- Micromedics, Inc.
- Affected units
- 273
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 (1)
- Lot Number: 163010 Expiration date: June 2021
Distribution
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