Z-2853-2017Class II
Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into...
Intl. Medsurg Connection, Inc. / initiated 2017-06-23 / Terminated / root cause: sterility
International Medsurg Connection, Inc. began a recall of Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are... on . FDA classified it as Class II and gives the reason as "Insufficient documentation to support product sterility claims". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-2853-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Intl. Medsurg Connection, Inc.
- Product
- Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
- Product code
- FMF Syringe, Piston
- Reason for recall
- Insufficient documentation to support product sterility claims.
- Root cause tag
- sterility
- FDA root cause
- Under Investigation by firm
- Action
- The firm, International Medsurg Connection Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 23, 3017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine affected product, return the product, and notify customer to either return unprocessed product in shipping cases or destroy items in opened cartons and to Acknowledge receipt of this notification by one of the following: email: [email protected]; phone at 847-619-9926 or fax to 847-619-9927. If you have any questions, contact Quality Manager at 847-619-9926 or email: [email protected].
- Quantity in commerce
- 54,204,100 units total
- Distribution
- Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
- Product codes and lots
- Catalog No. SY35005LL. Known Lot No. ("x" represents any release number): 12-6780-x, 12-6925-x, 12-6968-x, 12-7060-x, 12-7119-x, 12-7144-x, 12-7177-x, 12-7208-x, 12-7258-x, 12-7259-x, 12-7324-x, 12-7325-x, 12-7363-x, 12-7391-x, 12-7412-x, 12-7463-x, 12-7469-x, 12-7472-x, 12-7499-x, 13-6780-x, 13-7538-x, 13-7560-x, 13-7581-x, 13-7648-x, 13-7667-x, 13-7702-x, 13-7704-x, 13-7719-x, 13-7733-x, 13-7761-x, 13-7841-x, 13-7920-x, 13-7950-x, 13-7966-x, 13-7988-x, 13-8006-x, 13-8032-x, 13-8039-x, 13-8082-x, 13-8083-x, 13-8084-x, 13-8143-x, 13-8144-x, 13-8145-x, 13-8149-x, 13-8184-x, 13-8185-x, 13-8489-x, 13-8272-x, 14-8327-x, 14-8335-x, 14-8354-x, 14-8385-x, 14-8386-x, 14-8396-x, 14-8440-x, 14-8441-x, 14-8442-x, 14-8457-x, 14-8509-x, 14-8512-x, 14-8513-x, 14-8540-x, 14-8541-x, 14-8542-x, 14-8583-x, 14-8628-x, 14-8631-x, 14-8696-x, 14-8737-x, 14-8794-x, 14-8807-x, 14-8829-x, 14-8863-x, 14-9851-x, 14-9015-x, 14-9035-x, 14-9064-x, 14-9081-x, 15-0113-x, 15-9333-x, 15-9350-x, 15-9351-x, 15-9364-x, 15-9377-x, 15-9442-x, 15-9447-x, 15-9492-x, 15-9550-x, 15-9587-x, 15-9605-x, 15-9630-x, 15-9638-x, 15-9639-x, 15-9716-x, 15-9723-x, 15-9759-x, 15-9797-x, 15-9805-x, 15-9860-x, 15-9873-x, 15-9876-x, 15-9963-x, 16-0366-x, 16-0399-x, 16-0439-x, 16-0441-x, 16-0473-x, 16-0527-x, 16-0624-x, 16-0632-x, 16-0655-x, 16-0736-x, 16-0783-x, 16-0839-x, 16-0904-x, 16-0969-x, 16-1005-x, 16-1023-x, 16-1040-x, 16-1053-x, 16-1054-x, 16-1055-x, 16-1079-x, 16-1101-x, 16-1102-x, 16-1153-x, 16-1165-x, 17-1443-x, 17-1492-x, 17-1527-x, 17-1535-x, 17-1557-x, 17-1562-x, 17-1575-x, 17-1609-x, 17-1613-x, 17-1617-x, 17-1624-x, 17-1637-x, 17-1691-x, 17-1715-x, 17-1791-x.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2804-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2805-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2806-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2807-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2808-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2809-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2810-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2811-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2812-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2813-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2814-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2815-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2816-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2817-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2818-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2819-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2820-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2821-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2822-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2823-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2824-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2825-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2826-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2827-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2828-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2829-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2830-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2831-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2832-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2833-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2834-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2835-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2836-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2837-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2838-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2839-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2840-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2841-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2842-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2843-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2844-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2845-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2846-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2847-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2848-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2849-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2850-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2851-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2852-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2853-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2854-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2855-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2856-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2857-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2858-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2859-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2860-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2861-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2862-2017 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.