CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report

Various Pacemaker Packs, Cardio Thoracic Packs recalled

American Contract Systems is recalling Various Pacemaker Packs, Cardio Thoracic Packs, distributed in 13 states. The recall was initiated on 16 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASING, 2107102, 817211, 64116041 3) LSRSMVEINB, 2107221, 810211, 64119459 4) LSRCFHENDAE, 2107171, 807211, 64116602 5) UICT16E, 2108183, 771211, 15066268 6) BHOH94I, 2104141, 897211, 63987116-006 7) BHOH95, 2104301, 902211, 44123693-005 8) ANCV60AI, 2105201, 860211, 63956881-006 9) UDIP97AD, 2105201, 860211, 14858003-004 10) CEFS17I, 2105262, 855211, 44132805-005 11) FHPM10P, 2106092, 840211, 44129541-005 12) SLCV01E, 2107081, 812211, 64110741-006 13) SLEP03F, 2108271, 761211, 44314505-005 14) SLEP03F, 2108271, 761211, 44314504-005 15) CXCV91X, 2108311, 757211, 44315778-005 16) MECV98V, 2108312, 757211, 44313827-005 17) SAPA90X, 2108311, 758211, 64204754-006 18) SLCV01E, 2109161, 742211, 64208360-006 19) MEEP10F, 2109202, 740211, 64220361-006 20) UMOH42C, 2105072, 876211, 64061399-006 21) BHON40H, 2108122, 778211, 64095875-006 22) BHPM60F, 2108122, 779211, 44216056-005 23) BHCA27C, 2109072, 754211, 63997844-006 24) BHPM60F, 2109292, 728211, 44353475-005

Quantity recalled24 units

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-1691-2022
FDA event ID: 90574
Recalling firm: American Contract Systems, Kansas City, MO
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jun 2022
FDA classified: 8 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Pacemakers & Defibrillators

Timeline

16 Jun 2022	Recall initiated by company
8 Sep 2022	Classified by FDA	+84 days
14 Sep 2022	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

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

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

Various Pacemaker Packs, Cardio Thoracic Packs

Where it was distributed

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Arizona Florida Iowa Illinois Massachusetts Minnesota Missouri Nebraska Ohio Pennsylvania Rhode Island South Dakota Texas

Questions about this recall

Is Various Pacemaker Packs, Cardio Thoracic Packs recalled?

Yes. American Contract Systems recalled Various Pacemaker Packs, Cardio Thoracic Packs on 16 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1691-2022.

Why was it recalled?

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Which lots are affected?

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASING, 2107102, 817211, 64116041 3) LSRSMVEINB, 2107221, 810211, 64119459 4) LSRCFHENDAE, 2107171, 807211, 64116602 5) UICT16E, 2108183, 771211, 15066268 6) BHOH94I, 2104141, 897211, 63987116-006 7) BHOH95, 2104301, 902211, 44123693-005 8) ANCV60AI, 2105201, 860211, 63956881-006 9) UDIP97AD, 2105201, 860211, 14858003-004 10) CEFS17I, 2105262, 855211, 44132805-005 11) FHPM10P, 2106092, 840211, 44129541-005 12) SLCV01E, 2107081, 812211, 64110741-006 13) SLEP03F, 2108271, 761211, 44314505-005 14) SLEP03F, 2108271, 761211, 44314504-005 15) CXCV91X, 2108311, 757211, 44315778-005 16) MECV98V, 2108312, 757211, 44313827-005 17) SAPA90X, 2108311, 758211, 64204754-006 18) SLCV01E, 2109161, 742211, 64208360-006 19) MEEP10F, 2109202, 740211, 64220361-006 20) UMOH42C, 2105072, 876211, 64061399-006 21) BHON40H, 2108122, 778211, 64095875-006 22) BHPM60F, 2108122, 779211, 44216056-005 23) BHCA27C, 2109072, 754211, 63997844-006 24) BHPM60F, 2109292, 728211, 44353475-005

Where was it sold?

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

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.

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