CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report
Integra¿ Bone Marrow Biopsy Trays recalled
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling Integra¿ Bone Marrow Biopsy Trays, distributed in Maryland. The recall was initiated on 22 Sep 2015 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-0193-2016
- FDA event ID
- 72274
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2015
- FDA classified
- 29 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 22 Sep 2015 | Recall initiated by company | |
| 29 Oct 2015 | Classified by FDA | +37 days |
| 4 Nov 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
Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.
Product as listed by the FDA
Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.
Where it was distributed
US Distributed to the state of : MD.
Questions about this recall
Is Integra¿ Bone Marrow Biopsy Trays recalled?
Yes. Integra LifeSciences Corp. d.b.a. Integra Pain Management recalled Integra¿ Bone Marrow Biopsy Trays on 22 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0193-2016.
Why was it recalled?
Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.
Which lots are affected?
There are 3 Integra Lot Numbers affected by the recall of the single lot of Hospira Lidocaine: W1501193, W1504141, W1505078 Catalogue No. 3404253
Where was it sold?
US Distributed to the state of : MD.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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