MHC Medical Recalls EasyTouch Insulin Syringes Due to Labeling Error
MHC Medical Products LLC is recalling 46,600 EasyTouch insulin syringes because retail shelf cartons may display an incorrect lot number.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and packaging labeling error (incorrect lot number on cartons) with no reported injuries or functional defects in the medical device.
Plain-English summary
MHC Medical Products LLC is recalling 46,600 units of the EasyTouch (ET) Insulin Syringe 29G 0.5ml (Item 829555). The recall is limited to Lot 45016. The product is intended for the injection of U100 insulin only.
The recall was initiated because the retail shelf cartons for these syringes may be labeled with an incorrect lot number. This is a documentation and labeling issue rather than a defect in the syringe itself.
The affected products were distributed nationwide in the states of AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WV, as well as in Puerto Rico. Consumers should check their syringes for Lot 45016 and contact MHC Medical Products LLC for further instructions.
The recalled product
- Product
- EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
- Manufacturer
- MHC Medical Products LLC
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 46,600
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 45016
Distribution
Part of a larger recall action
This product is one of 2 recalled by MHC Medical Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · MHC Medical Products LLC
See all →- ModerateMHC Medical Recalls EasyTouch Insulin Syringes Due to Lot Labeling Error
FDA (Devices) · 2018-05-16
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