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FDA Medical Device Recalls (openFDA)

Winco Mfg., LLC: NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.

Recall number
Z-1461-2012
Recalling firm
Winco Mfg., LLC
Product
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.
Status
Terminated
Initiated
2012-02-06
Posted
2012-04-25
Terminated
2012-07-27
Reason
Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this
Root cause
Device Design
Action
Winco Mfg. sent an "URGENT DEVICE RECALL" letter dated February 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete the Caster Recall Replacement Form and return it to the firm's Customer Service Department via fax to 352-854-9544. Contact the Customer Service Department at 800 237-3377 for questions regarding this notice.
Quantity
96 Casters (32 Chairs)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.
Lot, serial or model codes
Model 6980, 6988
510(k) numbers
not on file
PMA numbers
not on file
Product code
INM
Firm FEI
1027229
Firm city
Ocala
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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