Oridion Surestream CO2 Sampling Lines- SureLine Adult Part Number: 010976-03 Product Usage: The intended use of SureStre
FDA device recall Z-1346-2012 · posted 2012-03-30 · Terminated
Recall details
- Recalling firm
- Oridion Medical 1987 Ltd.
- Reason for recall
- Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
- Action taken
- Oridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at technicalsupport@oridion.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 19 units (475 boxes)
- Distribution
- USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
- Date initiated
- 2011-12-01
- Date posted
- 2012-03-30
- Date terminated
- 2012-06-04
- Location
- Jerusalem, Har Hotzvim Industrial Park, Israel
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAC-LINE CO2 NASAL CANNULA SAMPLE LINE (K012391) | Oridion Medical 1987 , Ltd. | 2001-08-15 |