Reported Aug 2, 2017 · Terminated
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
- Lot codes and dates
- Model No. 61000:
- Product UPN
70 of 70 codes
20613994846604: Lot No. 20160208652016030859201603153820160405392016040859201605026820160505562016051179201605C063201605C064201605C065201605C066201605C067201605C068201605C06920160602752016060525201606089620160608972016061082201606108320160610842016061476201606147720160614782016061479201606148020160707272016070744201607075320160709622016070963201607C046201607C04720160803492016081585201608158620160815872016090237201609059320160905942016091409201609141020161005712016100572201610087520161008762016110851201611085220161111302016111131201611113220161111332016120836201612C03720170100522017020120201702012220170210652017021066
- Model 62000Product
- UPN
20613994846642: Lot No. 2016040236201604054020160411962016051245201605C015201605C0162016060226201606052620160608992016061085201606108620160614822016070542201607096420160709652016080350201608158820160815892016091146201610065420161104532016110854201612083720170105832017010945201701C037201702106720170210682017030596201703C1042017040147
- Amount recalled
- 63053 (48180 US) (14873 OUS)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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