—#188374

Product

TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K930217
Affected lot / code info: Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229; Serial Numbers: 0001330956; 0001331229;

Why it was recalled

Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

Root cause (FDA determination)

Packaging process control

Action the firm took

On 07/15/2021, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via FedEx to customers/distributors informing them that the firm has confirmed a complaint regarding an open packaging seal, breaking the sterile barrier. Customers are instructed to: 1. Please check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destroyed per their local facilitys destruction process. 2. Share this notice with any users of the product within their facilities to ensure they are also aware of this Urgent Medical Device Correction. 3. If they purchased this product from a distributor, contact their distributor for further instructions. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process your replacement. 5. Please contact their Recalling Firm's representative to assist in this process or they may also contact the number below for further assistance. The Recalling Firm will: 1. Issue replacements for all customers affected by the recall following receipt of the completed Customer Response Form. 2. taken action to prevent recurrence of this product issue. For questions or assistance contact (Recall Questions/Product Complaints/Technical Questions): North American Regional Complaint Center 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted M-F 8am - 5pm CT

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan

Timeline

Recall initiated: 2021-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.