Gyn-Disposables, Inc.
Memphis, TN, US
Gyn-Disposables, Inc. appears in FDA device records in Memphis, TN. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 168 recalls for this company.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Gyn-Disposables, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medikmark, Incorporatedrecall
- Stradis Healthcare510(k), enforcement report, recall
- Stradis Medical, LLC dba Stradis Healthcareenforcement report, recall
510(k) clearance history
FDA records hold 2 510(k) clearances for Gyn-Disposables, Inc. between 2007 and 2016. The busiest year on record is 2007, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2016 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
Showing 25 of 168| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0948-2023 | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0947-2023 | Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0946-2023 | Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0945-2023 | Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0944-2023 | Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0943-2023 | McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0942-2023 | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0941-2023 | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0940-2023 | HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0939-2023 | HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0938-2023 | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0937-2023 | HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0936-2023 | HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0935-2023 | PICC KIT, 10/CS, ACCESS MEDICAL LABEL | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0934-2023 | Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case; | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0933-2023 | Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0932-2023 | PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc. | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0931-2023 | Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0558-2023 | STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0557-2023 | HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0556-2023 | HENRY SCHEIN, Vas Pack, Item No.888-2520, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0555-2023 | STRADIS HEALTHCARE, Breast, Item No.693-276, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0554-2023 | STRADIS HEALTHCARE, Angio Pack, Item No.686-199, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0553-2023 | STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified | |
| Z-0552-2023 | STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain