CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
Chest Tube Tray (Cardiovascular Surgical Instruments recalled
Centurion Medical Products is recalling Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit), distributed nationwide in the US. The recall was initiated on 23 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0942-2015
- FDA event ID
- 70081
- Recalling firm
- Centurion Medical Products, Williamston, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Oct 2014
- FDA classified
- 8 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 23 Oct 2014 | Recall initiated by company | |
| 8 Jan 2015 | Classified by FDA | +77 days |
| 14 Jan 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Product as listed by the FDA
Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
Where it was distributed
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
Nationwide AlabamaGeorgiaIndianaMassachusettsNew YorkPennsylvaniaRhode Island
Questions about this recall
Why was it recalled?
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Which lots are affected?
CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750 Expiration date, both lots: 2016-03
Where was it sold?
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 70081This product is part of a recall event; the main page for the event is Diagnostic Imaging Tray (General Surgery convenience kit) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diagnostic Imaging Tray (General Surgery convenience kit) recalled | Centurion Medical Products | Particulate Matter | Nationwide | |
| CLASS II | Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) recalled | Centurion Medical Products | Particulate Matter | Nationwide | |
| CLASS II | Nerve Block Tray (Nerve Block convenience kit) recalled | Centurion Medical Products | Particulate Matter | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Centurion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalled | Centurion Medical Products | Sterility | Nationwide |
| Device | CLASS II | Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled | Centurion Medical Products | Sterility | Nationwide |
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Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |