Embecta Medical II LLC recalls EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated…
Reason for recall
Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Lot / code information
No UDI/All products labeled "for Investigational Use Only"
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3179-2026
- FDA 510(k) clearance · K212015The device's official FDA premarket clearance record
- FDA device classification · FMIOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5570The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find embecta Medical II LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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