Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
USBoston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Recalling Firm: Galt Medical Corporation
Reason for Recall / Hazard
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Product Description & Identification
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Affected Products
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Additional Source Details
| Field | Value |
|---|---|
| City | Garland |
| State | TX |
| Event id | 99369 |
| Address 1 | 2220 Merritt Dr |
| Code info | UDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G22262229 G22262230 G22292231 G22292232 G22292233 G22292234 G22292235 G22292236 G22292237 G22320238 G22320239 G22320240 G22320241 G22320242 G22320243 G22320244 G22354191 G22362192 G22362194 G22362195 R23083454 G23076104 G23076105 G23083106 G23083107 G23083108 G23083109 G23111110 G23111111 G23111112 G23111113 G23111114 G23111115 G23146116 G23146117 G23146118 G23146119 G23146121 G23146120 G23174122 G23174123 G23174124 G23174125 G23174126 G23174127 G23202128 G23202129 G23202130 G23202131 G23202132 G23202133 G23237134 G23237135 G23094468 G23237136 G23237137 G23237138 G23237139 G23237159 G23265140 G23265141 G23265142 G23265143 G23265144 G23265145 G23293146 G23293147 G23293148 G23293149 G23293150 G23293151 G23328152 G23328153 G23328154 G23328156 G24110621 G24110621 G24113622 G24113623 G24113625 G24113... [TRUNCATED] |
| Postal code | 75041-6137 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 114,260 kits |
| Reason for recall | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260626 |
| Initial firm notification | Letter |
| Center classification date | 20260807 |
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Overview
- Recalling FirmGalt Medical Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of MN.
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🚨 SAFETY ALERT: Galt Medical Corporation - Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock Check if your household is affected: https://therecallfile.com/recalls/boston-scientific-enhance-transcarotid-peripheral-access-kit-ref-sr-4f/FDA-Z-2917-2026
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