FDA (Devices) recall action 65689

Hospira Inc. recalled 9 products on 2013-08-14

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-08-14
Critical: 0
Units: 701,870

Why these products were recalled

It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

LowFDA (Devices)··2013-08-14
Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk
Hospira Inc. is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Recalls Blood Sets Due to Potential Bag Puncture Risk
Hospira is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk
Hospira is recalling 1,152 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Recalls Y-Type Blood Sets Due to Potential Bag Puncture
Hospira Inc. is recalling 3,600 units of Y-Type Blood Sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are d
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Recalls Blood Sets Due to Potential Puncture of Blood Bags
Hospira Inc. is recalling 96 units of PLUM BLOOD SETS because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170 Micron Filter, Prepierced Port, Non-Vented, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 600
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Recalls Y-Type Blood Sets Due to Potential Bag Puncture
Hospira is recalling 1,976 Y-type blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin and Non-Vented Pin, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood
Category
Distribution
1 state
SevereFDA (Devices)··2013-08-14
Hospira Recalls Y-Type Blood Sets Due to Piercing Pin Defect
Hospira Inc. is recalling 1,104 Y-type blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed fo
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk
Hospira is recalling 240 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
Category
Distribution
1 state
HighFDA (Devices)··2013-08-14
Hospira Recalls Secondary Blood Sets Due to Piercing Pin Defect
Hospira Inc. is recalling 672 units of secondary blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administrati
Category
Distribution
1 state