Z-2249-2021Class II

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

Name: Z-2249-2021 TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow...
Creator: Bard Peripheral Vascular Inc
Published: 2021-06-23
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2021-06-23 / Open, Classified / root cause: packaging

FDA source

Bard Peripheral Vascular Inc began a recall of TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm on 2021-06-23. FDA classified it as Class II and gives the reason as "Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2249-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-23
Posted: 2021-08-12
Recalling firm: Bard Peripheral Vascular Inc
Product: TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Product code: KNW Instrument, Biopsy
Reason for recall: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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
Quantity in commerce: 1,200 device
Distribution: 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
Product codes and lots: Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229; Serial Numbers: 0001330956; 0001331229;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2249-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2247-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-18	2021-08-11
Z-2248-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-18	2021-08-11
Z-2249-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-18	2021-08-11

Product code KNW

K930217Class IIBaxter Disposable Intraosseous Infusion NeedleBaxter Healthcare Corp / cleared 1994-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)