MONARCH Inflation Device recall: Sterility Concern
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Why was MONARCH Inflation Device recalled?
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF/UDI-DI/Lot(Expiration): IN2430/B/00884450298053/H2918428(4/22/2027). IN2530/B/00884450298060/H2918429(4/22/2027), H2925194(4/22/2027), H2929405(4/29/2027), H2934699(5/5/2027), H2937986(5/12/2027), H2943479(5/26/2027), H2978085(6/3/2027), H2982496(6/10/2027). IN2130/B/00884450298022/H2918427(4/22/2027), H2925193(4/22/2027), H2929404(4/29/2027), H2934698(5/5/2027), H2937984(5/12/2027), H2943477(6/3/2027), H2972585(5/26/2027), H2982494(6/10/2027).
- Product
- MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 12,910
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.
- Recall date
- October 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)