Recall Z-0085-2027
- Recall number
- Z-0085-2027
- Event number
- 99655
- Firm
- Stryker Sustainability Solutions
- Firm FEI
- 3009350690
- Product code
- NLH
- Status
- Open, Classified
- Initiated
- 2026-08-18
- Posted
- 2026-10-05
- Root cause
- Packaging process control
- 510(k) numbers
- K030187, K030279, K180710, K160242, K211276, K181056, K221067, K250772, K161464, K242225, K061045, K221854, K150357, K101789, K203655, K160303, K090323, K052414, K043393, K161393, K161827, K153153, K012523, K193263, K181618, K030026, K043392, K181897, K112292, K233825
Product#
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Reason for Recall#
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.