Medline Industries, Inc.
Laceration/Drape LTX Drape KIT
1manufacturer
164catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | PKD |
| Device type | Laceration Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4014 |
| Premarket notification | Exempt |
| Record published | 2024-04-14 |
| Record revised | 2024-07-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 6, case of 4, case of 3, case of 5, case of 16 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ59900A | In distribution | |
| DYNDA2415A | In distribution | |
| DYNJ80611B | In distribution | |
| DYNJ85048 | In distribution | |
| DYNDL2001 | In distribution | |
| DYNJ80611C | In distribution | |
| DYNDL1965 | In distribution | |
| DYNDL2009 | In distribution | |
| DYNDL1935A | In distribution | |
| DYNJ59308D | In distribution | |
| DYNJ80585D | In distribution | |
| DYNDL1962 | In distribution | |
| DYNJ57577A | In distribution | |
| DYNDL1682A | In distribution | |
| DYNJ57131D | In distribution | |
| DYNJ63368A | In distribution | |
| DYNDL1919 | In distribution | |
| DYNJ52103G | In distribution | |
| DYNJ909552A | In distribution | |
| DYNDA2868A | In distribution | |
| DYNJ61497C | In distribution | |
| DYNJ84667 | In distribution | |
| DYNDA3191A | In distribution | |
| DYNJ68955B | In distribution | |
| DYNJ82835B | In distribution | |
| DYNJ80686A | In distribution | |
| DYNJ86815 | In distribution | |
| DYNDA2881 | In distribution | |
| DYNJ56677B | In distribution | |
| DYNDL1996 | In distribution | |
| DYNDL1544A | In distribution | |
| DYNJ0807503N | In distribution | |
| DYNJ84651B | In distribution | |
| DYNJ89008 | In distribution | |
| DYNJ52103J | In distribution | |
| DYNJ64863A | In distribution | |
| DYNJ85144A | In distribution | |
| DYNDL1718A | In distribution | |
| DYNDL1975 | In distribution | |
| DYNDL1986 | In distribution | |
| DYNDL1992 | In distribution | |
| DYNDL1976 | In distribution | |
| DYNDA3149A | In distribution | |
| DYNDL1690A | In distribution | |
| DYNDR1283 | In distribution | |
| DYNDA1431B | In distribution | |
| DYNDA3149 | In distribution | |
| DYNDL1902A | In distribution | |
| DYNJ54326A | In distribution | |
| DYNJ66230B | In distribution | |
| DYNJ80664 | In distribution | |
| DYNJ81910A | In distribution | |
| DYNJ80502B | In distribution | |
| DYNDL1461A | In distribution | |
| DYNDL1981 | In distribution | |
| DYKMBNDL200A | In distribution | |
| DYNJ83526 | In distribution | |
| DYNJ65887B | In distribution | |
| DYNJ84637 | In distribution | |
| DYNJ80686 | In distribution | |
| DYNJ57915D | In distribution | |
| DYNDL1961 | In distribution | |
| DYNJT3342 | In distribution | |
| DYNDA2960 | In distribution | |
| DYKM2714 | In distribution | |
| DYNJ58743A | In distribution | |
| DYNDA3196 | In distribution | |
| PHS863717C | In distribution | |
| DYNJ80611A | In distribution | |
| DYNJ84351 | In distribution | |
| DYNJ56987C | In distribution | |
| DYNJ80611 | In distribution | |
| DYNDL1994 | In distribution | |
| DYNDL1495A | In distribution | |
| DYNJ85838 | In distribution | |
| DYNJ84637A | In distribution | |
| DYNJ80611D | In distribution | |
| DYNJ55228G | In distribution | |
| DYNJ28298I | In distribution | |
| DYNDL1973 | In distribution | |
| M101498 | In distribution | |
| DYNJ61497D | In distribution | |
| DYNDL1741B | In distribution | |
| DYNDA2868 | In distribution | |
| DYNDA2415B | In distribution | |
| DYNDA3197 | In distribution | |
| DYNDA3192 | In distribution | |
| DYNDL1963 | In distribution | |
| DYNJ80585B | In distribution | |
| DYNJ60726A | In distribution | |
| DYNJ68267B | In distribution | |
| DYNJ52157K | In distribution | |
| DYNJ55228I | In distribution | |
| DYNDL1965A | In distribution | |
| PHS751688G | In distribution | |
| DYNDR1287 | In distribution | |
| DYNJ85727 | In distribution | |
| DYNJ84651 | In distribution | |
| DYNDL1979 | In distribution | |
| DYNJ52103I | In distribution | |
| DYNJ52157I | In distribution | |
| DYNJ52157J | In distribution | |
| DYNJ68513A | In distribution | |
| DYNJ80585A | In distribution | |
| DYNJ67565A | In distribution | |
| DYNDR1281 | In distribution | |
| DYNDL1974A | In distribution | |
| PHS863717D | In distribution | |
| DYNJ84651A | In distribution | |
| DYNJ908773 | In distribution | |
| DYNJT3291 | In distribution | |
| DYNJ64379C | In distribution | |
| DYNJ52713F | In distribution | |
| DYNJ84651C | In distribution | |
| DYNJ88081 | In distribution | |
| DYNDA3191 | In distribution | |
| DYNJ88147B | In distribution | |
| DYNJ56508I | In distribution | |
| DYNDL2007 | In distribution | |
| DYNDL1997A | In distribution | |
| DYNDA3192A | In distribution | |
| DYNJ85718 | In distribution | |
| DYNDL1985 | In distribution | |
| DYKS2001 | In distribution | |
| M101565 | In distribution | |
| DYNJ67429B | In distribution | |
| DYNDA3202 | In distribution | |
| DYNJ86560 | In distribution | |
| DYNJ52713G | In distribution | |
| DYNJ86815A | In distribution | |
| DYNJRA1583D | In distribution | |
| DYNJ85718B | In distribution | |
| DYNDL1980A | In distribution | |
| DYNDL1921A | In distribution | |
| DYNJ67429C | In distribution | |
| DYNDL1982 | In distribution | |
| DYNJ85048A | In distribution | |
| DYNDL1991 | In distribution | |
| M101560 | In distribution | |
| DYNJT3172 | In distribution | |
| DYNDL1983 | In distribution | |
| DYNDL1997 | In distribution | |
| DYNDL1807B | In distribution | |
| DYNJ58634C | In distribution | |
| DYNDA2881A | In distribution | |
| DYNDL1988 | In distribution | |
| DYNJ0807503O | In distribution | |
| DYNJ80585C | In distribution | |
| DYNJ54819D | In distribution | |
| DYNDA3213 | In distribution | |
| DYNDL1989 | In distribution | |
| DYNDL1403A | In distribution | |
| DYNDL2003 | In distribution | |
| DYNJ89355 | In distribution | |
| DYNJ69096C | In distribution | |
| DYNDL1993 | In distribution | |
| DYNDL2006 | In distribution | |
| DYNJ58634D | In distribution | |
| DYNDL1974 | In distribution | |
| DYNDL1918 | In distribution | |
| DYNDL1935B | In distribution | |
| DYNJT3327 | In distribution | |
| DYNDA2883 | In distribution | |
| DYNJ59308B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Centurion Medical Products Corp | Medline Industries, Inc. | 67 |
| Cardinal Health | Cardinal Health 200, LLC | 64 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 8 |
| Stradis Healthcare | Stradis Healthcare | 7 |
| Centurion | Centurion Medical Products Corporation | 4 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 1 |
| MediChoice | Owens & Minor Distribution, Inc. | 1 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | 924 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 108 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 108 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-12-24 | Class II | Packaging change control | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. | 216 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-21 | Class II | Nonconforming Material/Component | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. | 1494 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 66 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 22 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.