Z-0676-2017Class II

ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow...

Name: Z-0676-2017 ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow...
Creator: Teleflex Medical
Published: 2016-11-08
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-11-08 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration... on 2016-11-08. FDA classified it as Class II and gives the reason as "Sterility: Due to a potential incomplete seal on the outer sterile package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0676-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Posted: 2016-11-30
Terminated: 2019-11-20
Recalling firm: Teleflex Medical
Product: ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, 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
Product code: KNW Instrument, Biopsy
Reason for recall: Sterility: Due to a potential incomplete seal on the outer sterile package.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected]. 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.
Distribution: Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.
Product codes and lots: Material # 9451-VC-006, Lot numbers: 010183, 010560, 010780, 010951, 010972, 011042, 011050, 011348, 011382, 011583, 011709, 011952, 012343, 012568, 012690, 013071, 013247, 013470, 013692, 013735, 013898, 014125, 014138, 014232, 014312 & 014565 and 9458-VC-006, Lot numbers: 010182, 010436, 010437, 010561, 010562, 010723, 010781, 010782, 010817, 010872, 010893, 010952, 010953, 010964, 010969, 010977, 011039, 011040, 011041, 011060, 011061, 011223, 011378, 011379, 011555, 011556, 011557, 011710, 011711, 011712, 011949, 011950, 011951, 012143, 012144, 012145, 012146, 012344, 012345, 012346, 012460, 012461, 012462, 012575, 012576, 012577, 012691, 012692, 012693, 012897, 012898, 013072, 013086, 013248, 013249, 013250, 013471, 013472, 013473, 013694, 013695, 013696, 013734, 013904, 013905, 013906, 013907, 014116, 014117, 014118, 014119, 014129, 014130, 014131, 014132, 014193, 014194, 014195, 014196, 014313, 014314, 014315, 014402, 014404, 014405, 014406, 014607, 014608 & 014609.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0676-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0675-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0676-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0677-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0678-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30
Z-0679-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-30

Product code KNW

K142377Class IIThe OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC / cleared 2014-12-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)