Reported Dec 7, 2016 · Terminated
ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow…
Teleflex Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 2917 Weck Dr · Research Triangle Park, NC · 27709-0186
Is this the product you have?
- ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only
- Manufactured forTeleflex Medical, 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
- Lot codes and dates
- Material # 9408-VC-006
- Lot numbers
85 of 85 codes
010256010257010438010439010556010557010737010738010739010946010947011037011046011047011048011215011216011217011380011381011383011384011385011675011676011945011946011947012139012140012141012142012353012354012355012356012463012464012465012570012572012573012686012687012688012895012896013074013084013085013122013185013255013256013257013258013477013478013688013894
- Lot numbers
010184010440010559010949011052011218011374011386 011720011948012352012459012578012689012894013060013246013468013509013689013891014121014139014168014197014203014310014425 & 014617
- Amount recalled
- 113,647 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Sterility: Due to a potential incomplete seal on the outer sterile package.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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