FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
- Recall number
- Z-1262-2007
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.
- Status
- Terminated
- Initiated
- 2007-08-15
- Posted
- 2007-09-25
- Terminated
- 2011-05-13
- Reason
- Expiration Dating; Some Convenience Kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.
- Root cause
- Error in labeling
- Action
- An August 22, 2007, Product Correction/Removal letter was issued to all distributors requesting return of affected lots and sub recall notification to their consignees.
- Quantity
- 16,333 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Merit Lot Numbers: A339685, A342805, A343855, A344934, A348869, A350784, A350904, A353811, A355556, A357384, A357617, A358608, A360773, A361301, A364800,A365752, A366125, A366523, A367651, A371190, A372815, A374857, A375138, A375848, A376973, A377976, A381997, A384786, A387975, F390117, F399800, F406192, F434870, F440785, F440789, F440801, F440803, F442051, F449479, F449481, F449482, F449483, F453020, F453170, F455150, F456553, F465539, F465540, F470421, F471056, F471659, F473566, F474320, F476314, F476367, F476543, F476597, F477729, F480127, F480129, F480131, F480140, F482129, F482853, F488460, F488709, F488858, F489432, F491275, F491462, F491656, F491659, F492220, F492223, F494547, F495828, F496118, F496939, F502345, F504184, F505776, F505782, F505785, F505786, F505790, F505794, F505799, F508595, F509197, F511015, F513651, F514433, F514954, F514957, F515853, F517537, F517708, F518306, F520504, F523595, F526626, F528413, F534059, F536871, F537731, F538716, F548977, F548978.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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