FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Custom Convenience Kit
- Recall number
- Z-0191-05
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Custom Convenience Kit
- Status
- Terminated
- Initiated
- 2004-10-15
- Posted
- 2004-11-11
- Terminated
- 2004-12-15
- Reason
- Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use.
- Root cause
- Other
- Action
- All consignees were notified by sales reps either by visit or telephone beginning 10/18/2004
- Quantity
- 10202 kits
- Distribution
- Nationwide. No foreign distribution
- Lot, serial or model codes
- Catalog # K09-00318FP, Lot # A348888 Catalog # K09-00378R, Lot #''s A335890, A337933, A339213, A342799, A345077, A347860. Catalog # k09-00946MP, Lot # A353710. Catalog # K09-01732HP, Lot #''s A341495, A348992. Catalog # K09-03251TP, Lot # A347976. Catalog # K09-05064D, Lot # A343197. Catalog # K09-05218BP, Lot # A347495. Catalog # K09-05475DP, Lot #''s A340512, A343609, A350138. Catalog # K09-05588C, Lot # A342348. Catalog # K09-05604DP, Lot #A339243. Catalog # K09-05608DP, Lot #''s A339690, A349600. Catalog # K09-05894F, Lot # A342805. Catalog # K09-07970A, Lot #''s A342665, A345567. Catalog # K09-08150AP, Lot #A340352. Catalog # K09-90100T, Lot # A353161. Catalog # K10-00091MP, Lot # A349569. Catalog # K10-01684BP, Lot # A352021. Catalog # K10-02936CP, Lot # A349696. Catalog # K10-03091B, Lot # A347572. Catalog # K10-03237AP, Lot #''s A339280, A348945. Catalog # K10-03247P, Lot # A347910. Catalog # K10-03256P, Lot #''s A345788, A350183. Catalog # K10-03281P, Lot #''s A346956, A348009. Catalog # K12-01191C, Lot # A347022. Catalog # K12-01242P, Lot # A350194. Catalog # K12-01304P, Lot #''s A346945, A349053, A350907. Catalog # K12-01356P, Lot #''s A343540, A351436. Catalog # K12-01372P, Lot #''s A343539, A346944. Catalog # K12-01402P, Lot # A352329. Catalog # K12-01427P, Lot # A352036. Catalog # K12-01507P, Lot #''s A349066, A351446. Catalog # K12-01512, Lot # A348216. Catalog # K12-01560, Lot # A347564.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28