Medline Industries, LP: Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B
- Reason / hazard
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution. OUS distribution pending.
- Recall initiated
- 2026-04-27
- Code info
- DYNJ904900N UDI-DI 10198459504273 Lot 25LBB457 DYNJ67267B UDI-DI 10198459084331 Lot 25LBQ732 DYNJ9814630O UDI-DI 10195327587291 Lot 25LBD665 CDS983383L UDI-DI 10198459224577 Lot 25LBC092 DYNJ59397Q UDI-DI 10198459495427 Lot 25LMG049 DYNJT7315 UDI-DI 10198459620225 Lot 25LBO095 DYNJ25097I UDI-DI 10198459449550 Lot 25KBC747 DYNJ21925S UDI-DI 10195327105020 Lots 25KBD835 25LBR371 DYNJT6428 UDI-DI 10198459553660 Lot 26AMA602 DYNJ0785736M UDI-DI 10198459487149 Lot 25LMI831 SYNJ10307B UDI-DI 10195327007249 Lot 25LBE309
- Product quantity
- 49,654 kits total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98951
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