Convenience kits recalled for containing defective medical syringes
ROi CPS LLC is recalling medical convenience kits distributed with Merit syringes that were subsequently recalled by their manufacturer. Approximately 3,387 kits with multiple lot numbers were affected.
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: Class II medical device recall involving defective syringes distributed in clinical kits. No illnesses or injuries are reported in this notice. This represents a risk-of-harm product scenario where defective items were distributed, meeting the rubric criterion for High severity.
Plain-English summary
ROi CPS LLC is recalling regard Clinical Packaging Solutions, HT00376I (Item Number 800223009). These medical convenience kits were distributed with Merit syringes manufactured by Jiangsu Shenli Medical Production. The Merit syringes included in these kits were subsequently recalled by their manufacturer.
Approximately 3,387 kits were distributed with the following affected lot numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, and 96833RS. The distribution pattern is described as US nationwide distribution with presence in North Carolina.
Customers and healthcare facilities that received these kits should discontinue use and contact ROi CPS LLC for return or replacement instructions.
The recalled product
- Product
- regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 3,387
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 (20)
- GTIN 10194717114116
- Lot Numbers: 93697
- 94061
- 94452
- 94912
- 95813
- 96271
- 96464
- 96833
- 97051
- 97411
- 97893
- 98446
- 98913
- 99464
- 99912
- 100447
- 100757
- 101527
- 96833RS
Distribution
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