FDA Devices Verify with FDA Devices → Moderate Class II Terminated

Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray Name: PACK BASIC VIII CFH -2072667, Tray Number: LSRCFBVIIIPKD; e. Tray Name: PACK BREAST GARRAMONE, Tray Number: LSRGABRSB; f. Tray Name: PAC

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0964-2019.

Q: Where was the recalled product distributed?

Distribution: US Distribution is to Florida..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0964-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Reviewed byPlainRecalls Editorial, Product Recalls Editorial Team · June 6, 2026

Reported: March 6, 2019 Initiated: November 21, 2018 #Z-0964-2019 51,152 units total units

American Contract Systems, Inc. issued this FDA Devices recall on March 6, 2019. Classified as Moderate severity (Class II). Approximately 51,152 units total units are affected. The recall was issued because: Potential that product has not reached complete sterilization,. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-0964-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on November 21, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. American Contract Systems, Inc. is listed as the recalling firm, operating out of Bloomington, MN. Federal records indicate 51,152 units total units are affected.

The documented reason for this recall is: Potential that product has not reached complete sterilization, Distribution data in the federal record shows the product reached: US Distribution is to Florida.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity

Moderate

Units Affected

51,152 units total

Related Recalls

6 from same agency

Product Description

Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray Name: PACK BASIC VIII CFH -2072667, Tray Number: LSRCFBVIIIPKD; e. Tray Name: PACK BREAST GARRAMONE, Tray Number: LSRGABRSB; f. Tray Name: PACK CARDIAC CATH LH - 2073653, Tray Numbers: LSRCARDCATHF, LSRCFHCATHE; g. Tray Name: PACK CAROTID CFH - 2022261, Tray Number: LSRCFHCARC; h. Tray Name: PACK CAROTID CFH - 2070082, Tray Number: LSRCFHCARD; i. Tray Name: PACK CATH PACK CFH - 2065429, Tray Number: LSRCFHCATHD; j. Tray Name: PACK CYSTO-TUR CFH - 2066423, Tray Number: LSRCFHCYTURC; k. Tray Name: PACK D-C GYN CFH - 2023208, Tray Number: LSRCFHDCGYNC; l. Tray Name: PACK D-C LH - 2067690, Tray Number: LSRLMDCA; m. Tray Name: PACK EENT CFH - 2023005, Tray Number: LSRCFENTB; n. Tray Name: PACK EENT CFH - 2073904, Tray Number: LSRCFENTC; o. Tray Name: PACK ENDOSCOPIC LH - 2073429, Tray Numbers: LSRENDOSCOPG, LSRENDOSCOPH; p. Tray Name: PACK ENDOVENOUS LH - 2072299, Tray Number: LSRLMENDOVB; q. Tray Name: PACK GENERIC A - 2018972, Tray Number: LSRMISCA; r. Tray Name: PACK HP GYN LAPAROSCOPY LH -2067955, Tray Number: LSRHPGYND; s. Tray Name: PACK KNEE ARTHROSCOPY SMHS - 2065237, Tray Number: LSRKNEEARTHF; t. Tray Name: PACK OCCULAR DRAPE LH - 2034766, Tray Number: LSROCCULARC; u. Tray Name: PACK OPHTHALMOLOGY LH - 2034932, Tray Number: LSROPHTHALD; v. Tray Name: PACK PICC LINE LH - 2008070, Tray Number: LSRPICCLINEG; w. Tray Name: PACK SHOULDER SMHS - 2065241, Tray Number: LSRSHOULDERD; x. Tray Name: PACK SINGLE BASIN LH - 2064837, Tray Number: LSRSINGLEBA; y. Tray Name: PACK STOCK PACEMAKER CFH - 2069578, Tray Number: LSRCFHPACRE; z. Tray Name: PACK VAGINAL DELIVERY SMHS - 2068301, Tray Number: LSRVAGDELIVC; aa. Tray Name: PACK CYSTO DECATUR - 2047265, Tray Number: LSRDECYSTA; bb. Tray Name: PACK MINOR DECATUR - 2071628, Tray Number: LSRDEMINB

Reason for Recall

Potential that product has not reached complete sterilization,

Details

Recalling Firm: American Contract Systems, Inc.
Units Affected: 51,152 units total
Distribution: US Distribution is to Florida.
Location: Bloomington, MN

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0964-2019
Date reported	March 6, 2019
Date initiated	November 21, 2018
Recalling firm	American Contract Systems, Inc.
Units affected	51,152 units total
Distribution	US Distribution is to Florida.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

51,152 units total units affected — limited or regional distribution scale.

Regional (<10K units) —

Multi-state (10K – 100K units) ✓ This recall

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Potential that product has not reached complete sterilization,

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0964-2019.

Where was the recalled product distributed? ▼

Distribution: US Distribution is to Florida..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0964-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Recall Guides

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How the US Recall System Works

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Understanding Recall Severity Classes

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What to Do When a Product Is Recalled

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How to Check If Your Products Are Recalled

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Recalled Products in Your Home

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Most Recalled Product Categories

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Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Related Safety Data

Explore related product safety and public health data from federal sources.

Food Safety Inspections

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PlainFoodSafe →

Ingredient Safety Data

FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.

PlainIngredients →

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GetFoodFacts →

Drug Safety Information

FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.

PlainMeds →

Product Injury Data

CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.

PlainSafety →

Recall Checker

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Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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FDA Devices Moderate

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Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Accessed 2026-06-06 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).