Tiburon
Head and Neck Pack
24manufacturers in China registered for this device type
1catalogue number
26recalls on this code
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-09 |
| Record revised | 2022-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9195 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54,362 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| Halyard | Avid Medical, Inc. | 12,802 |
| ACS | American Contract Systems, Inc. | 10,337 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
Showing 12 of 113. All products under General Surgery Tray
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-29 | Class II | Process change control | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These | 846 units | |
| 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 36862 kits | |
| 2024-11-08 | Class II | Material/Component Contamination | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 973,785 total units | |
| 2024-11-08 | Class II | Nonconforming Material/Component | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | 512,786 total units | |
| 2023-08-16 | Class II | Material/Component Contamination | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | 13,351 total packs | |
| 2020-01-31 | Class II | Other | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown | 318,000 units | 2023-02-01 |
| 2020-01-31 | Class II | Vendor change control | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical go | 2,161,526 units (113, 711 additional units as of 2/25/20) | 2023-01-19 |
| 2018-11-16 | Class II | Unknown/Undetermined by firm | The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation. | 182 packs | 2019-11-04 |
| 2017-08-01 | Class II | Material/Component Contamination | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide” 22GA 1 inch Needles. BD subsequently recalled these needles because, ” Loose polypropylene particulate in the fluid path could be expelled out of the n | 184,102 kits | 2019-06-18 |
| 2012-01-27 | Not classified | Packaging change control | The Presource kits were assembled with Ethicon Sutures in new Tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization. | 18,300 kits | 2016-08-01 |
| 2011-12-23 | Not classified | No Marketing Application | The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance. | 15,369 kits in total | 2016-08-01 |
| 2011-12-23 | Not classified | No Marketing Application | The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance. | 15,369 kits in total | 2016-08-01 |
| 2011-12-12 | Not classified | PMA | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product. | 7,213 each | 2016-08-29 |
| 2011-09-30 | Not classified | Component design/selection | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturers do not have all necessary FDA registrations or filings needed for these components. | 2016-08-01 | |
| 2011-09-03 | Not classified | Component design/selection | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product. | 2016-08-01 | |
| 2011-01-28 | Not classified | Nonconforming Material/Component | Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized. | 4.395 modules | 2012-09-04 |
| 2006-09-27 | Not classified | Other | The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use. | 1,026 modules | 2008-05-09 |
| 2006-09-27 | Not classified | Other | The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use. | 633 packs | 2008-05-09 |
| 2006-09-27 | Not classified | Other | The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use. | 3,533 packs | 2008-05-09 |
| 2005-10-03 | Not classified | Other | The procedure kits labeled as latex-free may contain a 4′ or 6′ ultra-weave premium elastic bandage containing dry, natural rubber latex. | 2006-12-21 | |
| 2005-10-03 | Not classified | Other | The procedure kits labeled as latex-free may contain a 4′ or 6′ ultra-weave premium elastic bandage containing dry, natural rubber latex. | 2006-12-21 | |
| 2003-06-27 | Not classified | Other | The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized. | 2005-09-22 | |
| 2003-06-27 | Not classified | Other | The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized. | 2005-09-22 | |
| 2003-06-27 | Not classified | Other | The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized. | 2005-09-22 | |
| 2003-06-27 | Not classified | Other | The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized. | 2005-09-22 | |
| 2003-06-27 | Not classified | Other | The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized. | 1242 packs total – all five kits | 2005-09-22 |
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.