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JAMSHIDI SN7016XRecalls & reported problems

Carefusion 2200, Inc · JAMSHIDI NEEDLE BIOPSY 16G X 70MM DISP · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403076206), received between Jan 25, 2021 and Jan 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Labelling, Instructions for Use or Training Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 25, 2021Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

    MATERIAL NO: SN (B)(6); BATCH NO: 0001372706. IT WAS REPORTED THAT: CUSTOMER RECEIVED BOX(ES) WITH DIFFERING EXPIRATION DATES. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: THE CUSTOMER BELOW CALLED ME EARLIER REGARDING ITEM SN (B)(6) AND IT HAVING 2 EXPIRATION DATES FOR THE SAME LOT # 0001372706. PLEASE SEE THE PICTURES BELOW OF THE LABEL AND THE PACKAGING. THE SYSTEM SHOWS 6-30-25 FOR THE EXPIRATION DATE WHICH IS ON THE BOX SO HE WANTS TO CONFIRM IF YOU CAN SEND A LETTER STATING THAT IS THE TRUE EXPIRATION DATE OR DO THEY NEED TO OPEN A PRODUCT COMPLAINT? QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1-COMPLAINT DETERMINATION TREE ¿ (NASSC-RCC-001).

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 11227515 ↗

Other Tray, surgical, needle devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.