IV Start Kit Recalled Due to Supplier Saline Syringe Issue
Medical Action Industries is recalling 206,200 IV Start Kits due to saline syringes recalled by the supplier. The affected kits were distributed in Minnesota and North Dakota.
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: This is an FDA Class II recall of a sterile medical device. Although no illnesses or injuries have been reported, IV Start Kits are risk-of-harm products used in patient care, and defects in saline syringes could pose potential safety risks.
Plain-English summary
Medical Action Industries, Inc. is recalling 206,200 IV Start Kits. Each kit contains a 5-milliliter saline flush syringe (REF 74654). The recall was initiated because these saline syringes were recalled by the supplier.
The affected kits include lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961 (UDI-DI 10809160020388). The kits were distributed in Minnesota and North Dakota only. There was no distribution to foreign countries, military, or government agencies.
Healthcare facilities that received these kits should contact Medical Action Industries, Inc. or the FDA for guidance on whether to discontinue use and how to obtain replacements.
The recalled product
- Product
- IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
- Manufacturer
- Medical Action Industries, Inc. 306
- Category
- Medical Device — IV Equipment
- Hazard
- Affected units
- 206,200
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 (17)
- Lot numbers 299477
- 299849
- 302983
- 304173
- 305500
- 305501
- 305514
- 306363
- 306683
- 307030
- 307809
- 310701
- 310887
- 311741
- 312807
- and 313961
- UDI-DI 10809160020388.
Distribution
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