PlainRecordsFDA · Medical device recall
"***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular… and 4 more products
- Date posted by the FDA
- Feb. 16, 2012
- Status
- Terminated
- Filed by
- Integra Neurosciences PR, Inc.
- Reason
- The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
5 products in this recall
"***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use…
- Product
- "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter
- Quantity
- 241 units
- Codes and lots
- 1010344, 1011451, 1021637, 1030061, 1032742, 1040738, 1041561, 1052595, 1053121, 1053487, 1080115, 1080148, 1081155, 1082137
- Recall started
- Nov. 28, 2011
- Device type
- Shunt, Central Nervous System And Components
- Root cause (FDA)
- Labeling mix-ups
- What the company told customers
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Recall number
- Z-1047-201
"***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g…
- Product
- "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
- Quantity
- 320 units
- Codes and lots
- 1010046, 1010346, 1010779, 1011037, 1011159, 1011277, 1011590, 1021465, 1030665, 1031019, 1031525, 1070018, 1071032, 1072560, 1073567, 1083958
- Recall started
- Nov. 28, 2011
- Device type
- Shunt, Central Nervous System And Components
- Root cause (FDA)
- Labeling mix-ups
- What the company told customers
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Recall number
- Z-1048-2012
"***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro…
- Product
- "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***" Collars for lumbar peritoneal shunt
- Quantity
- 63 units
- Codes and lots
- 1021597, 1031020, 1071033, 1092906, 1094646, 1100128, 1101134
- Recall started
- Nov. 28, 2011
- Device type
- Shunt, Central Nervous System And Components
- Root cause (FDA)
- Labeling mix-ups
- What the company told customers
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Recall number
- Z-1049-2012
"***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g…
- Product
- "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
- Quantity
- 357 units
- Codes and lots
- 1030725, 1032722, 1040610, 1041158, 1041360, 1042200, 1050184, 1052919, 1052985, 1060593, 1060778, 1060985, 1061498, 1061571, 1061831, 1062078, 1084389, 1090768, 1092765
- Recall started
- Nov. 28, 2011
- Device type
- Shunt, Central Nervous System And Components
- Root cause (FDA)
- Labeling mix-ups
- What the company told customers
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Recall number
- Z-1050-2012
"***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD…
- Product
- "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058"***Plainsboro, NJ***" Step down connector to be secure with ligature
- Quantity
- 322 units
- Codes and lots
- 1011261, 1020752, 1020887, 1021660, 1030180, 1031438, 1031740, 1041562, 1042443, 1050389, 1050897, 1052789, 1052981, 1053298, 1061717, 1072920, 1073554, 1081985, 1082859, 1090536, 1091830, 1092604
- Recall started
- Nov. 28, 2011
- Device type
- Shunt, Central Nervous System And Components
- Root cause (FDA)
- Labeling mix-ups
- What the company told customers
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Recall number
- Z-1051-2012
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1047-201, Z-1048-2012, Z-1049-2012, Z-1050-2012, Z-1051-2012. The agency record governs; check it and the company before acting.