Manus Medical, LLC
Henrico, VA, US
Manus Medical, LLC appears in FDA device records in Henrico, VA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Manus Medical, LLC 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.
- Custom Healthcare Systems, Inc.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1121091 | 1121091 | Manus Medical, LLC | 4205 EUBANK ROAD, Henrico, VA 23231 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0863-2020 | Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit | A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX. | Class II | Terminated | |
| Z-0268-2019 | CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0267-2019 | CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0266-2019 | CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0265-2019 | CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0264-2019 | CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0263-2019 | CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0262-2019 | CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0261-2019 | CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0260-2019 | CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0259-2019 | CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0258-2019 | CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0257-2019 | CHS Custom Convenience Kit- COBAN, LF (1"X5 YDS) Product Number:D5-14591 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0256-2019 | CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0255-2019 | CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0254-2019 | CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0253-2019 | CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0252-2019 | CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0251-2019 | CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0250-2019 | CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0249-2019 | (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0248-2019 | CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0247-2019 | CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0246-2019 | CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated | |
| Z-0245-2019 | CHS Custom Convenience Kit-SPECIALIST CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain