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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Surgical Convenience Kits Recalled Due to Sterility Breach Risk

Agency Publication Date: June 28, 2024
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Summary

Medline Industries is recalling 81,044 surgical and convenience kits because they contain a 'Pure Pouch' component with weak seals. These weak seals can break, causing the medical instruments inside (like scissors and forceps) to lose their sterile status. Using non-sterile surgical tools can lead to serious patient infections. These kits, including various Birthing Room, Neuro, and Intubation packs, were distributed to healthcare facilities across 23 U.S. states.

Risk

A weak seal on the internal pouches can fail during transport or storage, exposing the sterile instruments to air and contaminants. This breach in sterility poses a medium risk of infection or medical complications if the compromised instruments are used during a surgical or medical procedure.

What You Should Do

  1. Identify if you have any of the affected Medline kits by checking the Pack Numbers and Lot Numbers on the outer packaging. Affected items include Sterile Retrograde Kits (Pack #DYNJ47873L, #DYNJ47873K), Neuro IR Packs (#DYNJ56073C), Birthing Room Packs (#DYNJ38429D), Cath Lab Packs (#DYNJ56141A), and various other specialty convenience trays.
  2. Check specifically for impacted lot numbers such as 23KBW512, 23IDA509, 23JMF534, 23HBK868, 23GMH075, 24ADA089, 24ADA460, and others listed in the product details, with expiration dates ranging from early 2024 through late 2027.
  3. Immediately stop using any kits that match the affected pack and lot numbers to prevent the use of potentially non-sterile instruments.
  4. Contact your healthcare provider or Medline Industries directly at 1-800-MEDLINE (1-800-633-5463) to receive instructions on returning the products and obtaining replacements.
  5. Quarantine the affected inventory to ensure it is not accidentally used in clinical settings.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and Return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Retrograde PK-22025203-LF (Pack #DYNJ47873L)
Model / REF:
DYNJ47873L
66175
UPC Codes:
10195327506896
40195327506897
Lot Numbers:
23KBW512 (Exp 8/31/2027)
Date Ranges: Exp 8/31/2027
Product: Medline Neuro IR Pack (Pack #DYNJ56073C)
Model / REF:
DYNJ56073C
DYNJ04048
UPC Codes:
10193489441833
40193489441834
Lot Numbers:
23IDA509 (Exp 5/31/2026)
23DDC159 (Exp 11/30/2025)
Date Ranges: Exp 5/31/2026, Exp 11/30/2025
Product: Medline Birthing Room Pack (Pack #DYNJ38429D)
Model / REF:
DYNJ38429D
65945
67645
Lot Numbers:
23JMF534 (Exp 12/31/2024)
23JMC032 (Exp 5/31/2024)
23HMD025 (Exp 5/31/2024)
23GMC207 (Exp 5/31/2024)
23HMH776 (Exp 5/31/2024)
Date Ranges: Exp 5/31/2024, Exp 12/31/2024
Product: Medline Retrograde PK-22025203-LF (Pack #DYNJ47873K)
Model / REF:
DYNJ47873K
66175
UPC Codes:
10193489466812
40193489466813
Lot Numbers:
23HBK868 (Exp 8/31/2027)
23HBC082 (Exp 2/29/2028)
23GBC462 (Exp 1/31/2028)
23DBK792 (Exp 11/30/2027)
Date Ranges: Exp 8/31/2027, Exp 2/29/2028, Exp 1/31/2028, Exp 11/30/2027
Product: Medline Cath Lab Pack (Pack #DYNJ56141A)
Model / REF:
DYNJ56141A
DYND0400
UPC Codes:
10193489555585
40193489555586
Lot Numbers:
23IBK595 (Exp 1/31/2025)
Date Ranges: Exp 1/31/2025
Product: Medline Sterile Loop Insertion Tray (Pack #DYNJ62843A)
Model / REF:
DYNJ62843A
DYNJ04048
UPC Codes:
10195327001766
40195327001224
Lot Numbers:
24ABP043 (Exp 12/31/2024)
23IBM893 (Exp 3/31/2025)
Date Ranges: Exp 12/31/2024, Exp 3/31/2025
Product: Medline Radiology Minor MVH (Pack #DYNJ63555C)
Model / REF:
DYNJ63555C
66175
UPC Codes:
10193489816525
40193489816526
Lot Numbers:
24ALA613 (Exp 3/31/2025)
23KLA748 (Exp 1/31/2025)
23KLA017 (Exp 1/31/2025)
23JLA853 (Exp 1/31/2025)
23JLA232 (Exp 1/31/2025)
23ILB006 (Exp 1/31/2025)
23ILA201 (Exp 12/31/2024)
23HLA429 (Exp 12/31/2024)
Date Ranges: Exp 12/31/2024, Exp 1/31/2025, Exp 3/31/2025
Product: Medline Basic Pack (Pack #DYNJ80649B)
Model / REF:
DYNJ80649B
DYND0400
UPC Codes:
10195327269944
40195327269945
Lot Numbers:
23JBG046 (Exp 5/31/2026)
Date Ranges: Exp 5/31/2026
Product: Medline Delivery Pack (Pack #DYNJ901130I)
Model / REF:
DYNJ901130I
DYND04000
UPC Codes:
10193489946055
40193489946056
Lot Numbers:
23GMH075 (Exp 7/31/2024)
23GMD605 (Exp 7/31/2024)
Date Ranges: Exp 7/31/2024
Product: Medline C-Section Pack (Pack #DYNJ902938J)
Model / REF:
DYNJ902938J
DYND04000
UPC Codes:
10193489946116
40193489946117
Lot Numbers:
23LMD530 (Exp 8/31/2024)
23IMG375 (Exp 8/31/2024)
23HMB336 (Exp 8/31/2024)
23GMF342 (Exp 8/31/2024)
23EMJ935 (Exp 8/31/2024)
23EMK254 (Exp 8/31/2024)
Date Ranges: Exp 8/31/2024
Product: Medline Open Heart CDS (Pack #CDS981759C)
Model / REF:
CDS981759C
DYNJ04048
UPC Codes:
10888277524002
Lot Numbers:
24ADA460 (Exp 7/31/2025)
23KDB724 (Exp 7/31/2025)
23JDA205 (Exp 10/31/2025)
23IDA683 (Exp 11/30/2025)
23EDA124 (Exp 5/31/2025)
Date Ranges: Exp 5/31/2025, Exp 7/31/2025, Exp 10/31/2025, Exp 11/30/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94239
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Authorized Medline Distributors; Hospitals and Healthcare Facilities
Manufactured In: United States
Units Affected: 8 products (12,588 total sterile kits; 12,588 total sterile kits; 12,588 total sterile kits; 12,588 total sterile kits; 7,673 total non-sterile kits; 7,673 total non-sterile kits; 7,673 total non-sterile kits; 7,673 total non-sterile kits)
Distributed To: Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.