InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost inst…
Olympus Corporation of the Americas · Potential for distal end of the sheath to break off during a procedure.
Open FDA's page for this record- Cfres ID
- 207542
- Product res number
- Z-1888-2024
- Event date initiated
- 2024-04-03
- Event date posted
- 2024-05-23
- Recall status
- Open, Classified
- Res event number
- 94545
- Product code
- EOB
- Firm FEI number
- 2429304
- Recalling firm
- Olympus Corporation of the Americas
- Address 1
- 3500 Corporate Pkwy
- City
- Center Valley
- State
- PA
- Postal code
- 18034-8229
- Additional info contact
- Cynthia Ow 647-9993203
- Reason for recall
- Potential for distal end of the sheath to break off during a procedure.
- Root cause description
- Under Investigation by firm
- Product quantity
- pending
- Distribution pattern
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
- Product description
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
- Code info
Model No. LCS4K30BTOL, LCS1530TPOL, LCS1830TPST, LCS4K30TPOL, LCS1545BTOL, LCS1845BTST, LCS4K45BTOL, LCS1545TPOL, LCS1845TPST, LCS4K45TPOL, LCS1570BTOL, LCS1870BTST, LCS4K70BTOL, LCS1570TPOL, LCS1870TPST, LCS4K70TPOL; UDI-DI: 00821925040137, 00821925040151, 00821925040144, 00821925040175, 00821925040168, 00821925040199, 00821925040182, 00821925040083, 00821925040076, 00821925040106, 00821925040090, 00821925040120, 00821925040113, 00821925040069; All Lot Numbers.
- Action
Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notification, dated 5/1/24. Consignees are instructed to read the provided labeling addendum, inspect their inventory to identify affected devices and place a copy of the addendum with the remaining inventory, ensure all required personnel are aware of this recall, notify those who received product further distributed, and acknowledge receipt of the recall notification using Olympus's recall portal. Consignees can report the incidence of a device breakage associated with this event to the Technical Assistance Center at 1-800-8489024, Option 1. Consignees with any questions can contact Olympus at 647-999-3203 or by email at Cynthia.Ow@olympus.com.
- K numbers
- K152531
- Harmonized identifiers (openFDA)
- Device name
- Nasopharyngoscope (Flexible Or Rigid)
- Medical specialty description
- Ear, Nose, Throat
- Regulation number
- 874.4760
- Device class
- 2
- K number
- K243639, K234096, K965233, K132009, K181240, K945381, K945081, K020599, K023004, K202727, K220465, K100125, K944670, K072387, K941565, K162410, K200609, K936257, K946011, K232015, K902683, K222587, K170285, K950809, K874215, K070752, K261544, K162916, K024095, K182102, K221638, K951201, K944861, K942265, K943074, K940028, K950603, K970247, K003830, K896297 +123 more
- Registration number
- 9710058, 9610877, 3014644276, 8044098, 3010220595, 1052728, 9611680, 3010202439, 9515015, 3004361445, 3015925378, 3023102955, 1928237, 3042172882, 3017636737, 1218141, 3013497507, 1643264, 3006154292, 3003637092, 3010264076, 1650907, 3015552886, 3014605202, 3012797688, 3011050570, 3025349506, 9614969, 3018094310, 3009134855, 3025482817, 3005216736, 2242464, 3004644065, 1221826, 9614641, 3003604053, 1221934, 1057421, 2243757 +92 more
- FEI number
- 1000116142, 3010220595, 3007130719, 3004361445, 3015925378, 1000208608, 3023102955, 1928237, 3003495548, 3042172882, 3017636737, 1218141, 3013497507, 3002807798, 1643264, 3006154292, 3003637092, 3010264076, 3002808001, 3007475226, 3003276727, 3015552886, 3014605202, 3012797688, 3011050570, 3025349506, 3018094310, 3009134855, 3025482817, 3005216736, 2242464, 3004644065, 1221826, 3003604053, 1221934, 1000499348, 2243757, 3016678045, 1000115586, 3004612223 +92 more