Sterile Medical Extension Sets Distributed Without Expiration Dates
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
What this means for you
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: This is a risk-of-harm product (sterile medical device) where injury has not yet been reported. Missing expiration dates on sterile devices prevents verification of sterility assurance, creating a potential patient safety risk.
Plain-English summary
Avanos Medical, Inc. is recalling sterile Y-connector extension sets that were distributed to healthcare facilities. The affected products are labeled as SUMMIT MEDICAL PRODUCTS (REF 220227) or MEDICAL PRODUCTS SPECIALISTS EXTENSION SET (Catalog Number BC00604), and serve as accessories for pain control pump systems.
The affected sterile extension sets were distributed without expiration dates. Expiration dating on sterile medical devices is required to enable healthcare providers to verify that product sterility has been maintained. Without proper expiration dating on these devices, the sterility assurance of the products cannot be confirmed.
Approximately 1,378 units with all lot codes are affected. Distribution was limited to healthcare facilities in 11 U.S. states: California, Colorado, Florida, Michigan, New Mexico, Ohio, Oregon, Tennessee, Texas, Utah, and Wisconsin.
Affected healthcare facilities should contact Avanos Medical, Inc. for further instructions regarding this recall.
The recalled product
- Product
- Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessor
- Manufacturer
- Avanos Medical, Inc.
- Affected units
- 1,378
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)
- ALL LOT CODES
Distribution
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