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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Custom Healthcare Systems, Inc.: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Agency Publication Date: October 25, 2018
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Affected Products

Product: CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B

Lot Number: 70618 Exp. Date: 9/1/2020

Lot Numbers:
Number
Product: CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

Lot Number: 70518, Exp. Date: 2/1/2021

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Number
Product: 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)Lot Number:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021

Lot Numbers:
Number
number
Product: CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B

Lot number: 52418 Exp. Date: 5/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623

Lot number: 52418 Exp. Date: 5/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP

Lot number: 51418 Exp. Date: 5/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178

Lot number: 52418 Exp. Date: 5/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635

Lot number: 51418 Exp. Date: 5/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914

Lot number: 51418 Exp. Date: 5/1/2021

Lot Numbers:
number
Product: (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

(1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021

Lot Numbers:
number
Number
Product: CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

Lot number: 70618 Exp. Date:1/1/2021

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number
Product: CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000

Lot number: 51018 Exp. Date:5/1/2021

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Product: CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

Lot number: 61918 Exp. Date: 6/1/2021

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number
Product: CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685

Lot number: (1) 71718 Exp. Date: 7/1/2021 (2) 70618 Exp Date: 7/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664

Lot number:51018 Exp. Date 5/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520

Lot number: 51418 Exp. Date: 5/1/2021

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Product: CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669

Lot number: 52418 Exp. Date: 5/1/2021

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Product: CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591

Lot number: 52418 Exp. Date: 5/1/2021

Lot Numbers:
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Product: CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538

Lot number: 51418 Exp. Date: 2/1/2021

Lot Numbers:
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Product: CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B

Lot number:51018 Exp Date: 5/1/2021 Exp. Date: 2/1/2021

Lot Numbers:
number
Product: CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

Lot number: 51418 Exp Date: 5/1/2021

Lot Numbers:
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Product: CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000

Lot number: 61518 Exp Date: 12/1/2020

Lot Numbers:
number
Product: CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914

Lot number: 52418 Exp Date: 5/1/2021

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Product: CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884

Lot number:52418 Exp Date: 5/1/2021

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Product: CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L

Lot numbers: W72018, W71218 Exp Date:7/1/2021

Lot Numbers:
numbers
Product: CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

Lot Number: :W72118 Exp Date:7/1/2021

Lot Numbers:
Number
Product: CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG

(1)1231-150L GOWN, RAGLAN, LG, NONREINF Lot Numbers: W72318,W72118 (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF Lot Number: W72318 (3) 1231-140XL GOWN, SPECIALTY XL, XLONG Lot Number: W71818 Exp. Date: 7/1/2021

Lot Numbers:
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Number
Number
Product: CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112

Lot Number: W72118 Exp. date: 7/1/2021

Lot Numbers:
Number
Product: CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400

Lot Number: 61518 Exp. date: 8/1/2020

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81179
Status: Resolved
Manufacturer: Custom Healthcare Systems, Inc.
Manufactured In: United States
Units Affected: 29 products (200 units; 40 units; (1) 750 units (2) 200 units; 150 units; 50 units; 30 units; 160 units; 100 units; 50 units; (1) 180 units (2)180 units; 630 units; 250 units; 72 units; 80 units; 48 units; 150 units; 50 units; 150 units; 150 units; 1250 units; 24 units; 48 units; 100 units; 60 units; 7200 units; 89 units; 72832 units; 4500 units; 300 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.