Device recall: CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
Class II FDA enforcement event 81179. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Custom Healthcare Systems, Inc. started this device recall on 13 Aug 2018. The firm address in the FDA record is in Richmond, VA. FDA put the recall in Class II. FDA event 81179 has 29 product records. The first FDA enforcement report date is 31 Oct 2018. The record gives the status Terminated, with the termination date 1 Aug 2022.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
Recalling firm
Custom Healthcare Systems, Inc., Richmond, VA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
29 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0240-2019 | CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B | 200 units | Class II | Terminated | 31 Oct 2018 |
| Z-0241-2019 | CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 | 40 units | Class II | Terminated | 31 Oct 2018 |
| Z-0242-2019 | CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502 | (1) 750 units (2) 200 units | Class II | Terminated | 31 Oct 2018 |
| Z-0243-2019 | CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B | 150 units | Class II | Terminated | 31 Oct 2018 |
| Z-0244-2019 | CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623 | 50 units | Class II | Terminated | 31 Oct 2018 |
| Z-0245-2019 | CHS Custom Convenience Kit-SPECIALIST CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP | 30 units | Class II | Terminated | 31 Oct 2018 |
| Z-0246-2019 | CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 | 160 units | Class II | Terminated | 31 Oct 2018 |
| Z-0247-2019 | CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 | 100 units | Class II | Terminated | 31 Oct 2018 |
| Z-0248-2019 | CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 | 50 units | Class II | Terminated | 31 Oct 2018 |
| 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 | (1) 180 units (2)180 units | Class II | Terminated | 31 Oct 2018 |
| Z-0250-2019 | CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 | 630 units | Class II | Terminated | 31 Oct 2018 |
| Z-0251-2019 | CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 | 250 units | Class II | Terminated | 31 Oct 2018 |
| Z-0252-2019 | CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C | 72 units | Class II | Terminated | 31 Oct 2018 |
| Z-0253-2019 | CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685 | 80 units | Class II | Terminated | 31 Oct 2018 |
| Z-0254-2019 | CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 | 48 units | Class II | Terminated | 31 Oct 2018 |
| Z-0255-2019 | CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 | 150 units | Class II | Terminated | 31 Oct 2018 |
| Z-0256-2019 | CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 | 50 units | Class II | Terminated | 31 Oct 2018 |
| Z-0257-2019 | CHS Custom Convenience Kit- COBAN, LF (1"X5 YDS) Product Number:D5-14591 | 150 units | Class II | Terminated | 31 Oct 2018 |
| Z-0258-2019 | CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 | 150 units | Class II | Terminated | 31 Oct 2018 |
| Z-0259-2019 | CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B | 1250 units | Class II | Terminated | 31 Oct 2018 |
| Z-0260-2019 | CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B | 24 units | Class II | Terminated | 31 Oct 2018 |
| Z-0261-2019 | CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 | 48 units | Class II | Terminated | 31 Oct 2018 |
| Z-0262-2019 | CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 | 100 units | Class II | Terminated | 31 Oct 2018 |
| Z-0263-2019 | CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884 | 60 units | Class II | Terminated | 31 Oct 2018 |
| Z-0264-2019 | CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L | 7200 units | Class II | Terminated | 31 Oct 2018 |
| 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 | 89 units | Class II | Terminated | 31 Oct 2018 |
| 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 | 72832 units | Class II | Terminated | 31 Oct 2018 |
| Z-0267-2019 | CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 | 4500 units | Class II | Terminated | 31 Oct 2018 |
| Z-0268-2019 | CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400 | 300 units | Class II | Terminated | 31 Oct 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 29Median of the firm: 2
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Dec 2019 | Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit | Device | Class II | 1 |
| 5 Nov 2014 | Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only. | Device | Class II | 1 |
| 26 Nov 2012 | Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile med | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-0240-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 81179. https://recallregister.com/fda/ii/81179/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- What quantity of product is in FDA event 81179?
- The event has 29 product records. The first record gives this quantity:
200 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.