CLASS II ONGOING Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Regard ¿ custom surgical pack labeled as "Lap recalled

ROi Consolidated Service Center (CSC) is recalling Regard ¿ custom surgical pack labeled as "Lap - Flol Lady OF Angels" including Stryker, distributed in Louisiana, Missouri. The recall was initiated on 21 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Number (Lot Number, Expiration Date): 800096004 (044343D, 43590); 800096004 (048023D, 43722); 800096004 (049262D, 43757); 800096004 (052020D , 43856); 800096004 (054482D, 43948); 800096004 (057619D, 44035); 800096005 (059908E , 44080); 800096005 (062938E , 44151); 800096005 (65606E, 44232);

Quantity recalled261 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2220-2019
FDA event ID: 82499
Recalling firm: ROi Consolidated Service Center (CSC), Springfield, MO
Classification: Class II
Status: Ongoing
Recall initiated: 21 Mar 2019
FDA classified: 8 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

21 Mar 2019	Recall initiated by company
8 Aug 2019	Classified by FDA	+140 days
14 Aug 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.

Where it was distributed

Distributed to LA and MO

Louisiana Missouri

Questions about this recall

Why was it recalled?

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Which lots are affected?

Item Number (Lot Number, Expiration Date): 800096004 (044343D, 43590); 800096004 (048023D, 43722); 800096004 (049262D, 43757); 800096004 (052020D , 43856); 800096004 (054482D, 43948); 800096004 (057619D, 44035); 800096005 (059908E , 44080); 800096005 (062938E , 44151); 800096005 (65606E, 44232);

Where was it sold?

Distributed to LA and MO

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82499

This product is part of a recall event; the main page for the event is Regard ¿ custom surgical pack labeled as "Laparoscopic recalled.

Reported	Class	Recall	Company	Reason	Where
14 Aug 2019	CLASS II	Regard ¿ custom surgical pack labeled as "Laparoscopic recalled	ROi Consolidated Service Center (CSC)	Packaging Defects	LA, MO

More recalls from ROi Consolidated Service Center (CSC)

All 2

Reported	Class	Recall	Company	Reason	Where
14 Aug 2019Device	CLASS II	Regard ¿ custom surgical pack labeled as "Laparoscopic recalled	ROi Consolidated Service Center (CSC)	Packaging Defects	LA, MO

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