Embecta Medical II Llc: Needle, Hypodermic, Single Lumen
embecta Medical II LLC is recalling approximately 100 Nano Pro pen needles (Catalog number 320550) that were labeled "For Investigational Use Only" but were mistakenly sold as regular commercial products. These needles were distributed nationwide across multiple states. The recall is classified as Class II, meaning the product could cause adverse health effects but is unlikely to cause serious injury.
- Recalling firm
- embecta Medical II LLC
- Product
- EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
- Reason
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2023-07-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a086f0c8-4f01-4122-b84d-39be0ede6e7b