Monoject Prefilled Syringe Plunger Defect Recall: Air Reintroduction Risk
Monoject prefilled syringes in medical kits may have a plunger that rebounds after air expulsion, potentially reintroducing air into the syringe. This FDA Class I recall affects approximately 9,378 units distributed in Florida and Pennsylvania.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I recall is classified as Severe per the severity rubric. The Class I designation establishes a minimum severity level despite no reported illnesses.
Plain-English summary
The FDA is recalling Monoject 0.9% Sodium Chloride Flush Prefilled Syringes (REF: 8881570121) manufactured by Cardinal Health. These syringes were distributed as components in five Aligned Medical Solutions procedure kits: AMS-9041CP, AMS-9046CP-1, AMS8939A, AMS9957A, and AMS12149.
The syringes have a potential defect where the plunger may draw back after air has been expelled, potentially reintroducing air into the syringe.
The recall affects approximately 9,378 units that were distributed to Florida and Pennsylvania. The syringes were manufactured and distributed between July 1, 2019, and July 2021. Persons who have received these kits should review the recall details and contact their supplier or the manufacturer for guidance on handling affected product.
The recalled product
- Product
- Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Sp
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- plunger-malfunction
- air-embolism-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Syringe Lots: All Lots manufactured and distributed between July 1
- 2019 and July 2021. Kit Model/Lots: AMS-9041CP/ 136833
- AMS-9046CP-1/ 137794
- AMS8939A/ 140390
- 141088
- 141096
- 141100
- 141102
- 146039
- 146349
- 147902
- 147903
- 148414
- 148452
- 148640
- 149132
- 149135
- 149485
- 141087
- 141097
Distribution
Distributed in 2 states:
- FL
- PA
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