Trinity Sterile Recalls Midline Catheter Dressing Change Kits Due to Seal Defects
Trinity Sterile, Inc. is recalling 2,970 Midline Catheter Dressing Change Kits with Statlock because evidence of foreign material in the seal caused improper sealing and compromised sterility.
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 recall is classified as FDA Class II, and the defect involves compromised sterility in a medical device used for vascular catheter maintenance, which poses a significant risk of infection or serious injury.
Plain-English summary
Trinity Sterile, Inc. is recalling 2,970 units of the Midline Catheter Dressing Change Kit with Statlock (Product Number: TRIO0000l). The recall was initiated because evidence of face masks or other material was found in the seal of several kits. This defect caused improper seals, which compromised the sterility of the product.
The affected product is intended to provide ongoing vascular catheter maintenance, such as dressing changes and catheter flushing. The recall covers Lot Number 600001, with an expiration date of April 30, 2022. The product was distributed nationwide in the states of Iowa, Illinois, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oklahoma, Texas, and Virginia.
Healthcare facilities and consumers should stop using the affected kits immediately. Users should check their inventory for the specific lot number and product number listed above. If the product is found, it should be quarantined and returned to the supplier or the manufacturer for credit or replacement, in accordance with standard recall procedures.
The recalled product
- Product
- Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
- Manufacturer
- Trinity Sterile, Inc.
- Affected units
- 2,970
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: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
Distribution
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