CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Special Procedure Pack convenience kit recalled

American Contract Systems is recalling American Contract Systems Special Procedure Pack convenience kit, distributed nationwide in the US. The recall was initiated on 6 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(1) Model No SLSP77G; UDI-DI 00191072198730; Lot 981241; Exp. Date 1/19/2025; (2) Model No EJAG58A; UDI-DI 00191072190093; Lot 982241; Exp. Date 1/18/2025.

Quantity recalled112

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-2520-2024
FDA event ID: 94908
Recalling firm: American Contract Systems, Kansas City, MO
Classification: Class II
Status: Ongoing
Recall initiated: 6 May 2024
FDA classified: 7 Aug 2024
Reported: 14 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

6 May 2024	Recall initiated by company
7 Aug 2024	Classified by FDA	+93 days
14 Aug 2024	Published in enforcement report	+7 days

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

Reason for recall

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

American Contract Systems Special Procedure Pack convenience kit

Where it was distributed

US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Nationwide California Kansas Maine Minnesota Missouri Nebraska South Dakota

Questions about this recall

Is Special Procedure Pack convenience kit recalled?

Yes. American Contract Systems recalled Special Procedure Pack convenience kit on 6 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2520-2024.

Why was it recalled?

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

Which lots are affected?

(1) Model No SLSP77G; UDI-DI 00191072198730; Lot 981241; Exp. Date 1/19/2025; (2) Model No EJAG58A; UDI-DI 00191072190093; Lot 982241; Exp. Date 1/18/2025.

Where was it sold?

US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

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

More recalls from American Contract Systems

All 210

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Convenience Kits, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
2 Sep 2026Device	CLASS II	Convenience Kit, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
2 Sep 2026Device	CLASS II	Convenience Kit, CV B PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
2 Sep 2026Device	CLASS II	Convenience Kit, D & C PACK recalled by American Contract Systems	American Contract Systems	Foreign Material	Nationwide
26 Aug 2026Device	CLASS II	medical procedure kits and trays labeled as: Crani Pack recalled	American Contract Systems	Sterility	IA, MN, MO

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