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Nephron Sterile Compounding Center LLC

Nephron Sterile Compounding Center LLC Recalls

All product recalls associated with Nephron Sterile Compounding Center LLC.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1081–1100 of 3680 recalls

Hydromorphone HCl Injection (Nephron) – Sterility Risk (2022)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 30, 2022Nationwide• Nephron Sterile Compounding Center LLC

Sklar Instruments IV Cath Dressing Tray (Trinity Sterile) – Latex Mislabeling (2022)

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Low

FDAJun 29, 2022Nationwide• Trinity Sterile, Inc.

Wolf-Pak Premium Dressing Kit (Trinity Sterile) – Latex Mislabeling (2022)

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Low

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FDAJun 29, 2022Nationwide• Trinity Sterile, Inc.

Wolf Pak Premium Dressing Kit (Trinity Sterile) – Latex Mislabeling (2022)

Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

Low

FDAJun 29, 2022Nationwide• Trinity Sterile, Inc.

CARTO VIZIGO Guiding Sheath (Biosense Webster) – Packaging Water Damage (2022)

Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.

Low

FDAJun 29, 2022Nationwide• Biosense Webster, Inc.

BD Intraosseous Needle Kit (Bard Access) – Stylet Removal Risk (2022)

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

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Nephron Sterile Compounding Center LLC Recalls

Recall Summary

Hydromorphone HCl Injection (Nephron) – Sterility Risk (2022)

Sklar Instruments IV Cath Dressing Tray (Trinity Sterile) – Latex Mislabeling (2022)

Wolf-Pak Premium Dressing Kit (Trinity Sterile) – Latex Mislabeling (2022)

Wolf Pak Premium Dressing Kit (Trinity Sterile) – Latex Mislabeling (2022)

CARTO VIZIGO Guiding Sheath (Biosense Webster) – Packaging Water Damage (2022)

BD Intraosseous Needle Kit (Bard Access) – Stylet Removal Risk (2022)

Neurology Packs (American Contract) – Sterilization Cycle Concern (2022)

Laparoscopy Packs (American Contract) – Sterilization Cycle Concern (2022)

Breast Abdominoplasty Pack (American Contract) – Sterilization Cycle Concern (2022)

D&C Pack (American Contract) – Sterilization Cycle Concern (2022)

Convenience Packs (American Contract) – Sterilization Cycle Concern (2022)

PICC Line Packs (American Contract) – Sterilization Cycle Concern (2022)

Pacemaker Packs (American Contract) – Sterilization Cycle Concern (2022)

C-Section Packs (American Contract) – Sterilization Cycle Concern (2022)

Angiography Packs (American Contract) – Sterilization Cycle Concern (2022)

ENT Packs (American Contract) – Sterilization Cycle Concern (2022)

OB/GYN Packs (American Contract) – Sterilization Cycle Concern (2022)

Hysterectomy Packs (American Contract) – Sterilization Cycle Concern (2022)

Port Insertion Packs (American Contract) – Sterilization Cycle Concern (2022)

Eye Packs (American Contract) – Sterilization Cycle Concern (2022)