Trinity Care Solutions Recalls Normal Saline Syringes Due to Sterility Concerns
Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.
The agency’s classification
FDA (Drugs): 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 involves a lack of assurance of sterility in a medical product, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Trinity Care Solutions, operating as Franck's Lab Inc, is recalling specific lots of Normal Saline 10 mL/10 mL Syringes. The affected products are identified by Rx # 28839 (Discard After 05/5/15) and Rx # 29163 (Discard After 05/8/15). The recall is limited to products distributed in Florida.
The recall was initiated due to a lack of assurance of sterility. This decision follows concerns associated with quality control procedures observed during a recent FDA inspection. The agency classifies this as a Class II recall.
Consumers and healthcare providers in Florida who possess these specific lots should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
- Manufacturer
- Franck's Lab Inc dba Trinity Care Solutions
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 (4)
- Rx # 28839
- Exp 05/5/15
- Rx # 29136
- Exp 05/8/15
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 30 recalled by Franck's Lab Inc dba Trinity Care Solutions under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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