FDA Device recall Z-1728-2019

Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Dis…

FDA Device
Class II
terminated
Published 2019-06-12

On 2019-06-12 the FDA classified a Class II recall of Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Dis… by Stryker, citing the heated tube sets were consistently leaking and detaching from the cassette.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1728-2019
Classification	Class II
Status	terminated
Initiated	2019-03-07
Published	2019-06-12
Last updated	2026-09-13 11:55 UTC
Company	Stryker
Distribution	US

Product

Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Reason

The heated tube sets were consistently leaking and detaching from the cassette.

Identifiers

code_info	UDI - 07613327055658; Lot numbers: 56004333, 56004335, 56004337, 56004342, 56004352, 56004375, 56004393, 56004419, 5… UDI - 07613327055658; Lot numbers: 56004333, 56004335, 56004337, 56004342, 56004352, 56004375, 56004393, 56004419, 56004421, 56004423, 56004435, 56004445, 56004447, 56004465, 56004481, 56004485, 56004512, 56004520, 56004534, 56004541, 56004575, 56004577, 56004586, 56004597, 56004602, 56004626, 56004630, 56004643, 56004645, 56004649, 56004651, 56004710, 56004723, 56004725, 56004741, 56004752, 56004754, 56004757, 56004782, 56004786, 56004793, 56004836, 56004838, 56004840, 56004850, 56004863, 56004884, 56005075, 56005077, 56005081, 56005083, 56005085, 56005087, 56005089, 56005091, 56005093, 56005110, 56005112, 56005114, 56005116, 56005117, 56005124, 56005126, 56005141, 56005143, 56005145, 56005147, 56005149, 56005164, 56005168, 56005171, 56005173, 56005175, 56005177, 56005186, 56005190, 56005192, 56005194, 56005218, 56005223, 56005230, 56005236, 56005247, 56005253, 56005269, 56005275, 56005292, 56005292, 56005299, 56005310, 56005349, 56005355, 56005362, 56005364, 56005366, 56005368

code_info

UDI - 07613327055658; Lot numbers: 56004333, 56004335, 56004337, 56004342, 56004352, 56004375, 56004393, 56004419, 5…

UDI - 07613327055658; Lot numbers: 56004333, 56004335, 56004337, 56004342, 56004352, 56004375, 56004393, 56004419, 56004421, 56004423, 56004435, 56004445, 56004447, 56004465, 56004481, 56004485, 56004512, 56004520, 56004534, 56004541, 56004575, 56004577, 56004586, 56004597, 56004602, 56004626, 56004630, 56004643, 56004645, 56004649, 56004651, 56004710, 56004723, 56004725, 56004741, 56004752, 56004754, 56004757, 56004782, 56004786, 56004793, 56004836, 56004838, 56004840, 56004850, 56004863, 56004884, 56005075, 56005077, 56005081, 56005083, 56005085, 56005087, 56005089, 56005091, 56005093, 56005110, 56005112, 56005114, 56005116, 56005117, 56005124, 56005126, 56005141, 56005143, 56005145, 56005147, 56005149, 56005164, 56005168, 56005171, 56005173, 56005175, 56005177, 56005186, 56005190, 56005192, 56005194, 56005218, 56005223, 56005230, 56005236, 56005247, 56005253, 56005269, 56005275, 56005292, 56005292, 56005299, 56005310, 56005349, 56005355, 56005362, 56005364, 56005366, 56005368

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1728-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.