MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument
FDA device recall Z-0113-2016 · posted 2015-10-08 · Terminated
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- small puncture marks in a sterile package for an accessory to an Olympus device
- Action taken
- A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FEQ
- Quantity affected
- 31060
- Distribution
- US (nationwide) and Canada.
- Date initiated
- 2015-09-11
- Date posted
- 2015-10-08
- Date terminated
- 2017-03-13
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (K100899) | Keymed (Medical & Industrial Equipment), Ltd. | 2010-09-13 |