EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
embecta Medical II LLC · Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Open FDA's page for this record- Cfres ID
- 221925
- Product res number
- Z-3179-2026
- Event date initiated
- 2023-07-26
- Event date posted
- 2026-09-16
- Recall status
- Open, Classified
- Res event number
- 99593
- Product code
- FMI
- Product description
- EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
- Code info
- No UDI/All products labeled "for Investigational Use Only"
- Firm FEI number
- 3022699058
- Recalling firm
- embecta Medical II LLC
- Address 1
- 300 Kimball Dr Ste 300 300 Kimball Dr
- Address 2
- Ste 300
- City
- Parsippany
- State
- NJ
- Postal code
- 07054-2184
- Additional info contact
- Heather Reed 978-387-4086
- Reason for recall
- Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 4300 Final Count (in EA)
- Distribution pattern
- 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.
- Action
On July 26, 2023, Embecta Medical II LLC ( subsidiary of Becton, Dickinson and Company 'BD's) issued a recall notification to consignees via email. Embecta ask consignees to take the following actions: 1. Immediately review your inventory for the specific Catalog (Ref) numbers listed above. If it is labeled with a "For investigational Use Only" statement, discard the product. 2. Share this advisory notification with anyone in your facility/office who may have received the product to ensure they are also aware of this advisory. 3. Identify all patients that may have received the affected product as defined in this notification. Provide a customer letter to all patients to advise them of this advisory notification on BD's behalf. An example of a patient communication is attached for your reference. 4.Complete the attached Customer Response Form whether or not you have any of the impacted material so that we may acknowledge your receipt of this notification.
- K numbers
- K212015
- Harmonized identifiers (openFDA)
- Device name
- Needle, Hypodermic, Single Lumen
- Medical specialty description
- General Hospital
- Regulation number
- 880.5570
- Device class
- 2
- K number
- K970383, K960933, K936029, K102584, K220603, K951515, K142765, K813648, K230635, K052843, K881654, K925086, K180545, K052408, K761098, K861318, K233037, K131954, K100124, K170824, K934435, K943794, K021315, K944114, K001853, K024109, K915409, K905664, K160887, K925056, K152877, K904295, K002180, K231723, K062956, K890620, K061032, K000085, K891919, K132583 +654 more
- Registration number
- 3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1836161, 1017768, 3004458481, 3006973666, 3004143450, 3017509841, 2032098, 1319211, 3010872792, 3016884191, 3003916417, 3015727296, 3014479313, 3009853488, 9610847, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 9614279, 3007007790, 2027487, 1000523114 +414 more
- FEI number
- 3003310007, 3018507299, 3005609751, 3003902757, 3013162291, 3004127962, 3047706961, 3010862763, 3014165712, 3000214934, 3006787036, 3004111573, 3010462274, 3017907716, 3020294761, 3003464075, 2020394, 1017768, 3004458481, 3006973666, 1000112877, 3008002452, 3004143450, 3017509841, 1319211, 3001570557, 3010872792, 3016884191, 3003169040, 3004521048, 1000174591, 3015727296, 3014479313, 3009853488, 3009746425, 2024024, 3003589279, 3011453824, 3019004087, 3007007790 +414 more