Recall Z-0678-2017
Teleflex Medical · initiated November 8, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
Codes / lots: Material # 9470-VC-006, Lot numbers: 010859 & 011511.
Reason for recall
Sterility: Due to a potential incomplete seal on the outer sterile package.
FDA-determined cause: Device Design
Action taken
Teleflex sent an Urgent Medical Device Recall Notification letter dated November 8, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product, complete the enclosed Recall Acknowledgement Form and fax to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to call their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 919-433-4940.
Details
- Recall number
- Z-0678-2017
- Initiated
- November 8, 2016
- Terminated
- November 20, 2019
- Product code
- KNW – Instrument, Biopsy
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0675-2017 Class II | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for:…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0676-2017 Class II | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0677-2017 Class II | ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |
| Z-0679-2017 Class II | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl…Sterility: Due to a potential incomplete seal on the outer sterile package. | 11/08/2016Terminated |