Z-0524-03
Stryker brand Neptune waste management system; model 711-27-1
Stryker Corp. / initiated 2002-12-03 / Terminated
Stryker Instruments, Instruments Div. began a recall of Stryker brand Neptune waste management system; model 711-27-1 on . The reason FDA records is "Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0524-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- Stryker brand Neptune waste management system; model 711-27-1.
- Product code
- FYD Apparatus, Exhaust, Surgical
- Reason for recall
- Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
- FDA root cause
- Other
- Action
- Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.
- Quantity in commerce
- 370
- Distribution
- United States
- Product codes and lots
- All systems with a rover top cap assembly 711-27-001 manufactured from 1/1/01 to 12/31/01. The recalled caps can be visually distinguished because there is a flat lip where the lid connects to the unit, and the flat lip is covered by a metal retaining ring which holds the cap in place. Non-recalled units do not have a metal retaining ring, rather the caps are held in place by screws with ribs in the cap on either side of each screw.
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